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{"sheet":"Results","index":1,"n_rows":239,"n_cols":85,"rows_kept":239,"cut":false,"hidden":false,"merged":[[0,0,0,12],[0,13,0,22],[0,80,0,83],[0,23,0,40],[0,41,0,53],[0,54,0,68],[0,69,0,79]]}
["Basic information",null,null,null,null,null,null,null,null,null,null,null,null,"Domain 1. Randomization process",null,null,null,null,null,null,null,null,null,"Domain 2. Deviations from intended interventions",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Domain 3. Missing outcome data",null,null,null,null,null,null,null,null,null,null,null,null,"Domain 4. Measurement of the outcome",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Domain 5. Selection of the reported result",null,null,null,null,null,null,null,null,null,null,"Domain 6. Overall Bias"]
["Time","Unique ID","Assessor","Study ID","Reference","Experimental","Comparator","Outcome","Results","Aim","Effect of adhering to intervention?","Weight","Sources","1.1","1.2","Note for 1.1&1.2","1.3","Note for 1.3","1.0 Algorithm result","1.0 Assessor's Judgement","1.0 General note","1.0 Optional Question","1.0 Note for optional question","2.1","2.2","Note for 2.1&2.2","2.3","Note for 2.3","2.4","Note for 2.4","2.5","Note for 2.5","2.6","Note for 2.6","2.7","Note for 2.7","2.0 Algorithm result","2.0 Assessor's Judgement","2.0 General Notes","2.0 Optional Question","2.0 Note for optional question","3.1","Note for 3.1","3.2","Note for 3.2","3.3","Note for 3.3&3.4","3.4","Note for 3.4 (not use)","3.0 Algorithm result","3.0 Assessor's judgement","3.0 General notes","3.0 Optional Question","3.0 Note for optional question","4.1","Note for 4.1","4.2","Note for 4.2","4.3","Note for 4.3","4.4","Note for 4.4&4.5","4.5","Note for 4.5 (not use)","4.0 Algorithm result","4.0 Assessor's Judgement","4.0 General note","4.0 Optional Question","4.0 Note for optional question","5.1","Note for 5.1","5.2","Note for 5.2","5.3","Note for 5.3","5.0 Algorithm result","5.0 Assessor's Judgement","5.0 General note","5.0 Optional Question","5.0 Note for optional question","Algorithm's overall Judgement","Assessor's overall Judgement","6.0 General Note","6.0 Optional Question","6.0 Note for optional question"]
["2022/01/16 09.11","AGH2002A1","AW&CC","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Fetal, neonatal or infant death","Fetal, neonatal or infant death","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","Y","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. ","N","Baseline variation was as expected given the small total sample size.","Low","Low","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. Baseline variation was as expected given the small total sample size.\r\n",null,null,"N","N","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat analysis was performed. ","NA",null,"Low","Low","The allocated treatment was masked and intention to treat analysis was performed. \r\n",null,null,"Y","No missing data for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome.\r\n\r\n\r\n",null,null,"N",null,"PN",null,"PN","Treating team were blinded to allocation of patients.","NA",null,"NA",null,"Low","Low","\r\n\r\nTreating team were blinded to allocation of patients. The outcome measure was objective. \r\n\r\n",null,null,"PY","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N","Numbers of deaths were reported both per pregnancy and per infant. ","Low","Low","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 09.11","AGH2002A2","AW&CC","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Fetal death","Fetal death","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","Y","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. ","N","Baseline variation was as expected given the small total sample size","Low","Low","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. Baseline variation was as expected given the small total sample size.\r\n",null,null,"N","N","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat analysis was performed. ","NA",null,"Low","Low","The allocated treatment was masked and intention to treat analysis was performed. \r\n",null,null,"Y","No missing data for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome.\r\n\r\n\r\n",null,null,"N",null,"N",null,"PN","Treating team were blinded to allocation of patients.","NA",null,"NA",null,"Low","Low","\r\n\r\nTreating team were blinded to allocation of patients. The outcome measure was objective. \r\n\r\n",null,null,"PY","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results .","N",null,"N",null,"Low","Low","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results .\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 09.11","AGH2002A3","AW&CC","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Neonatal Death","Neonatal Death","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","Y","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. ","N","Baseline variation was as expected given the small total sample size","Low","Low","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. Baseline variation was as expected given the small total sample size.\r\n",null,null,"N","N","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat analysis was performed. ","NA",null,"Low","Low","The allocated treatment was masked and intention to treat analysis was performed. \r\n",null,null,"Y","No missing data for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome.\r\n\r\n\r\n",null,null,"N",null,"N",null,"PN","Treating team were blinded to allocation of patients.","NA",null,"NA",null,"Low","Low","\r\n\r\nTreating team were blinded to allocation of patients. The outcome measure was objective\r\n\r\n",null,null,"PY","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results.","N","Outcome timing was defined at 28 days post birth. ","N","Numbers of deaths were reported both per pregnancy and per infant. ","Low","Low","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results.\r\nOutcome timing was defined at 28 days post birth. \r\nNumbers of deaths were reported both per pregnancy and per infant. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 09.12","AGH2002A5","AW&CC","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Respiratory distress syndrome","Respiratory distress syndrome","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","Y","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. ","N","Baseline variation was as expected given the small total sample size","Low","Low","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. Baseline variation was as expected given the small total sample size.\r\n",null,null,"N","N","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat analysis was performed. ","NA",null,"Low","Low","The allocated treatment was masked and intention to treat analysis was performed. \r\n",null,null,"Y","No missing data for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome.\r\n\r\n\r\n",null,null,"N","Outcome was as diagnosed by the treating team but case definition is unclear. ","N",null,"PN","Treating team were blinded to allocation of patients.","NA",null,"NA",null,"Low","Low","Outcome was as diagnosed by the treating team but case definition is unclear. \r\n\r\nTreating team were blinded to allocation of patients.\r\n\r\n",null,null,"PY","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results. ","PN",null,"N","Data were presented as simple numbers of events with descriptive statistics only. ","Low","Low","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results. \r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 09.18","AGH2002A8","AW&CC","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Chronic lung disease","Chronic lung disease","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","Y","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. ","N","Baseline variation was as expected given the small total sample size","Low","Low","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. Baseline variation was as expected given the small total sample size.\r\n",null,null,"N","N","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat analysis was performed. ","NA",null,"Low","Low","The allocated treatment was masked and intention to treat analysis was performed. \r\n",null,null,"Y","No missing data for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome.\r\n\r\n\r\n",null,null,"N","Outcome was as diagnosed by the treating team but case definition is unclear. ","PN",null,"PN","Treating team were blinded to allocation of patients.","NA",null,"NA",null,"Low","Low","Outcome was as diagnosed by the treating team but case definition is unclear. \r\n\r\nTreating team were blinded to allocation of patients.\r\n\r\n",null,null,"PY","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results. ","N","The time point of assessment was  clearly defined. Outcome definition was clear in published report. ","N","Simple descriptive statistics including event numbers and proportions with the event were reported. ","Low","Low","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results. Outcome definition was clear in published report. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 09.18","AGH2002A9","AW&CC","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Severe IVH","Severe IVH","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","Y","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. ","N","Baseline variation was as expected given the small total sample size","Low","Low","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. Baseline variation was as expected given the small total sample size.\r\n",null,null,"N","N","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat analysis was performed. ","NA",null,"Low","Low","The allocated treatment was masked and intention to treat analysis was performed. \r\n",null,null,"PY","For two babies the head ultrasound performed at the time of hospital discharge was missed. It is unclear whether they had been assigned to placebo or intervention but as per the protocol each would have had ultrasounds at day 1,3 and 7 for diagnosis of IVH. ","NA",null,"NA",null,"NA",null,"Low","Low","For two babies the head ultrasound performed at the time of hospital discharge was missed. It is unclear whether they had been assigned to placebo or intervention but both were born at term and therefore lower likelihood of severe IVH. ",null,null,"N","Measured by ultrasonography. ","PN","Ultrasonography was only performed for infants of birthweight less than 1500g. Median birthweight in the intervention group was 1840grams  and 2420g in the placebo group.","PN","Treating team were blinded to allocation of patients.","NA",null,"NA",null,"Low","Low","Measured by ultrasonography. \r\nUltrasonography was only performed for infants of birthweight less than 1500g. \r\nTreating team were blinded to allocation of patients.\r\n\r\n",null,null,"PY","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results","PN","IVH staging followed standard practice. ","N","Simple descriptive statistics were used and included simple event numbers and proportion of those with events in each group. ","Low","Low","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results\r\nIVH staging followed standard practice. \r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 09.18","AGH2002A11","AW&CC","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Necrotising enterocolitis","Necrotising enterocolitis","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","Y","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. ","N","Baseline variation was as expected given the small total sample size","Low","Low","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. Baseline variation was as expected given the small total sample size.\r\n",null,null,"N","N","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat analysis was performed. ","NA",null,"Low","Low","The allocated treatment was masked and intention to treat analysis was performed. \r\n",null,null,"Y","No missing data for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome.\r\n\r\n\r\n",null,null,"N","Outcome was as diagnosed by the treating team but case definition is unclear. ","PN",null,"PN","Treating team were blinded to allocation of patients.","NA",null,"NA",null,"Low","Low","Outcome was as diagnosed by the treating team but case definition is unclear. \r\n\r\nTreating team were blinded to allocation of patients.\r\n\r\n",null,null,"PY","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results","N",null,"N","Simple descriptive statistics including event numbers and proportions with the event were reported. ","Low","Low","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 09.19","AGH2002A12","AW&CC","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Composite serious outcome","Composite serious outcome","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","Y","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. ","N","Baseline variation was as expected given the small total sample size","Low","Low","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. Baseline variation was as expected given the small total sample size.\r\n",null,null,"N","N","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat analysis was performed. ","NA",null,"Low","Low","The allocated treatment was masked and intention to treat analysis was performed. \r\n",null,null,"Y","For two babies the head ultrasound performed at the time of hospital discharge was missed however this assessed only a single component of the composite outcome and they still had USS on days 1, 3 and 7. It is unclear whether they had been assigned to placebo or intervention. ","NA",null,"NA",null,"NA",null,"Low","Low","For two babies the head ultrasound performed at the time of hospital discharge was missed however this assessed only a single component of the composite outcome and they still had USS on days 1, 3 and 7. \r\n",null,null,"N",null,"PN","For multiple components of the composite, including retinopathy of prematurity, IVH and PVL, assessments were only performed for those infants <1500grams. Median birthweight in the intervention group was 1840grams  and 2420g in the placebo group.","PN","Treating team were blinded to allocation of patients.","NA",null,"NA",null,"Low","Low","\r\nFor multiple components of the composite, including retinopathy of prematurity, IVH and PVL, assessments were only performed for those infants <1500grams. Components were as diagnosed by the treating team but definitions were unclear.  \r\nTreating team were blinded to allocation of patients.\r\n\r\n",null,null,"PY","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results","PN","Time point for assessment of IVH and PVL could have differed but were not an influential component of the composite. ","N","Simple descriptive statistics including event numbers and proportions with the event were reported. ","Low","Low","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 09.19","AGH2002F1","AW&CC","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Gestational age at birth","Gestational age at birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","Y","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. ","N","Baseline variation was as expected given the small total sample size","Low","Low","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. Baseline variation was as expected given the small total sample size.\r\n",null,null,"N","N","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat analysis was performed. ","NA",null,"Low","Low","The allocated treatment was masked and intention to treat analysis was performed. \r\n",null,null,"Y","No missing data for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome.\r\n\r\n\r\n",null,null,"PN","Assessment method for gestational age not stated. ","PN","Likely to have followed standard methods and unlikely to have differed between groups. ","PN","Treating team were blinded to allocation of patients.","NA",null,"NA",null,"Low","Low","Assessment method for gestational age not stated. Likely to have followed standard methods and unlikely to have differed between groups. Treating team were blinded to allocation of patients.\r\n\r\n",null,null,"PY","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results","N",null,"N","Simple descriptive statistics including event numbers and proportions with the event were reported. ","Low","Low","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 09.19","AGH2002F2","AW&CC","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","SGA","<10th centile","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","Y","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. ","N","Baseline variation was as expected given the small total sample size","Low","Low","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. Baseline variation was as expected given the small total sample size.\r\n",null,null,"N","N","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat analysis was performed. ","NA",null,"Low","Low","The allocated treatment was masked and intention to treat analysis was performed. \r\n",null,null,"PY","No missing data for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome.\r\n\r\n\r\n",null,null,"PN",null,"PN","Ascertainment of birthweight was unlikely to have differed between treatment groups.","PN","Treating team were blinded to allocation of patients.","NA",null,"NA",null,"Low","Low","\r\nAscertainment of birthweight was unlikely to have differed between treatment groups.\r\nTreating team were blinded to allocation of patients.\r\n\r\n",null,null,"PY","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results","PN","SGA classification <10th centile is standard.","PN","Simple descriptive statistics including event numbers and proportions with the event were reported. ","Low","Low","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results.\r\nSGA classification <10th centile is standard.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 09.19","AGH2002F4","AW&CC","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Proven neonatal infection in NICU","Proven neonatal infection in NICU","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","Y","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. ","N","Baseline variation was as expected given the small total sample size","Low","Low","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. Baseline variation was as expected given the small total sample size.\r\n",null,null,"N","N","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat analysis was performed. ","NA",null,"Low","Low","The allocated treatment was masked and intention to treat analysis was performed. \r\n",null,null,"Y","No missing data for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome.\r\n\r\n\r\n",null,null,"N","Outcome was as diagnosed by the treating team but case definition is unclear. ","PN",null,"PN","Treating team were blinded to allocation of patients.","NA",null,"NA",null,"Low","Low","Outcome was as diagnosed by the treating team but case definition is unclear. \r\n\r\nTreating team were blinded to allocation of patients.\r\n\r\n",null,null,"PY","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results. ","PN",null,"N","Simple descriptive statistics with event numbers and proportion with the event were reported. ","Low","Low","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 09.19","AGH2002F7","AW&CC","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Retinopathy of prematurity","Retinopathy of prematurity","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","Y","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. ","N","Baseline variation was as expected given the small total sample size","Low","Low","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. Baseline variation was as expected given the small total sample size.\r\n",null,null,"N","N","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat analysis was performed. ","NA",null,"Low","Low","The allocated treatment was masked and intention to treat analysis was performed. \r\n",null,null,"Y","Retinopathy of prematurity assessments were only performed for those infants <1500grams. ","NA",null,"NA",null,"NA",null,"Low","Low","Retinopathy of prematurity assessments were only performed for those infants <1500grams. \r\n\r\n\r\n",null,null,"N","Method of measurement not stated but unlikely to have differed between groups. ","PN","Retinopathy of prematurity assessments were only performed for those infants <1500grams. Median birthweight in the intervention group was 1840grams  and 2420g in the placebo group.","PN","Treating team were blinded to allocation of patients.","NA",null,"NA",null,"Low","Low","Method of measurement not stated but unlikely to have differed between groups. \r\nRetinopathy of prematurity assessments were only performed for those infants <1500grams. Median birthweight in the intervention group was 1840grams  and 2420g in the placebo group.\r\nTreating team were blinded to allocation of patients.\r\n\r\n",null,null,"PY","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results. ","PN","Although only severe ROP was reported, this was specified as part of the composite outcome.","N","Simple descriptive statistics including event numbers and proportions with the event were reported. ","Low","Low","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 09.20","AGH2002F8","AW&CC","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Periventricular leukomalacia","Periventricular leukomalacia","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","Y","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. ","N","Baseline variation was as expected given the small total sample size","Low","Low","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. Baseline variation was as expected given the small total sample size.\r\n",null,null,"N","N","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat analysis was performed. ","NA",null,"Low","Low","The allocated treatment was masked and intention to treat analysis was performed. \r\n",null,null,"PY","For two babies the head ultrasound performed at the time of hospital discharge was missed. It is unclear whether they had been assigned to placebo or intervention but as per the protocol each would have had ultrasounds at day 1,3 and 7 for diagnosis of PVL. ","NA",null,"NA",null,"NA",null,"Low","Low","For two babies the head ultrasound performed at the time of hospital discharge was missed. It is unclear whether they had been assigned to placebo or intervention but as per the protocol each would have had ultrasounds at day 1,3 and 7 for diagnosis of PVL. \r\n\r\n\r\n",null,null,"N","Measurement by ultrasonography. ","PN","Ultrasonography was only performed for infants of birthweight less than 1500g. Median birthweight in the intervention group was 1840grams  and 2420g in the placebo group.","PN","Treating team were blinded to allocation of patients.","NA",null,"NA",null,"Low","Low","Measurement by ultrasonography. \r\nUltrasonography was only performed for infants of birthweight less than 1500g. Median birthweight in the intervention group was 1840grams  and 2420g in the placebo group.\r\nTreating team were blinded to allocation of patients.\r\n\r\n",null,null,"PY","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results. ","PN",null,"N","Simple descriptive statistics were used and included simple event numbers and proportion of those with events in each group. ","Low","Low","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. \r\n"]
["2022/01/16 09.20","AGH2002F10","AW&CC","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Patent ductus arteriosus","Patent ductus arteriosus (indomethacin treated)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","Y","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. ","N","Baseline variation was as expected given the small total sample size","Low","Low","Randomisation sequence computer-generated and centrally controlled by 1 pharmacist at each hospital who kept the randomisation code. Stratification: by gestational age (24-27 weeks; 28-30 weeks) and by hospital using block sizes of 2. Baseline variation was as expected given the small total sample size.\r\n",null,null,"N","N","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat analysis was performed. ","NA",null,"Low","Low","The allocated treatment was masked and intention to treat analysis was performed. \r\n",null,null,"Y","No missing data for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome.\r\n\r\n\r\n",null,null,"PN","Outcome was as diagnosed by the treating team. Outcome defined as \"indomethacin treated\" PDA. ","PN",null,"PN","Treating team were blinded to allocation of patients.","NA",null,"NA",null,"Low","Low","Outcome was as diagnosed by the treating team. Outcome defined as \"indomethacin treated\" PDA. \r\n\r\nTreating team were blinded to allocation of patients.\r\n\r\n",null,null,"PY","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results.","PN","The outcome specified in methods was PDA but only indomethacin treated PDA was reported (standard practice). ","N","Simple descriptive statistics including event numbers and proportions with the event were reported. ","Low","Low","Statistical plan, protocol or trial registration document not available but outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 12.48","GAR2009A1","AW&CM","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Fetal or neonatal or infant death","Perinatal death +infant death","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Conference abstract(s) about the trial","Y","Y","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence.","N","No marked imbalance of baseline characteristics. ","Low","Low","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","Normal saline placebo was used. The study syringes (betamethasone or saline) were completely covered by a label to conceal the contents after preparation by a research pharmacist.","NA",null,"NA",null,"NA",null,"Y","A modified intention to treat approach was used ","NA",null,"Low","Low","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. Intention-to-treat analysis was performed. ",null,null,"Y","Data available for >95% of those randomised.","NA",null,"NA",null,"NA",null,"Low","Low","Data available for >95% of those randomised.\r\n\r\n\r\n",null,null,"N",null,"N",null,"PN","The treatment was masked and outcome assessors were blinded. ","NA",null,"NA",null,"Low","Low","\r\n\r\nThe treatment was masked and outcome assessors were blinded. The outcome measure was objective. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results.","N","Outcome and timeframe were prespecified. ","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. \r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 12.48","GAR2009A2","AW&CM","Garite2009",2675224,"Repeat betamethasone","Placebo","Fetal death","Fetal death","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Conference abstract(s) about the trial","Y","Y","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence.","N","No marked imbalance of baseline characteristics. ","Low","Low","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","Normal saline placebo was used. The study syringes (betamethasone or saline) were completely covered by a label to conceal the contents after preparation by a research pharmacist.","NA",null,"NA",null,"NA",null,"Y","A modified intention to treat approach was used ","NA",null,"Low","Low","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. Intention-to-treat analysis was performed. ",null,null,"Y","No missing data for this outcome.","NA",null,"NA",null,"NA","Low","Low","Low","No missing data for this outcome.\r\n\r\n\r\n",null,null,"N",null,"N",null,"PN","The treatment was masked and outcome assessors were blinded. ","NA",null,"NA",null,"Low","Low","\r\n\r\nThe treatment was masked and outcome assessors were blinded. The outcome measure was objective. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ","N",null,"N",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. \r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 12.48","GAR2009A3","AW&CM","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Neonatal death","Neonatal death","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Conference abstract(s) about the trial","Y","Y","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence.","N","No marked imbalance of baseline characteristics. ","Low","Low","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","Normal saline placebo was used. The study syringes (betamethasone or saline) were completely covered by a label to conceal the contents after preparation by a research pharmacist.","NA",null,"NA",null,"NA",null,"Y","A modified intention to treat approach was used ","NA",null,"Low","Low","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. Intention-to-treat analysis was performed. ",null,null,"Y","Data available for >95% of those randomised.","NA",null,"NA",null,"NA",null,"Low","Low","Data available for >95% of those randomised.\r\n\r\n\r\n",null,null,"N",null,"N",null,"PN","The treatment was masked and outcome assessors were blinded. ","NA",null,"NA",null,"Low","Low","\r\n\r\nThe treatment was masked and outcome assessors were blinded. The outcome measure was objective. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ","N","Outcome was prespecified.","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. \r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 12.48","GAR2009A5","AW&CM","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Respiratory distress syndrome ","RDS in whole group","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Conference abstract(s) about the trial","Y","Y","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence.","N","No marked imbalance of baseline characteristics. ","Low","Low","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","Normal saline placebo was used. The study syringes (betamethasone or saline) were completely covered by a label to conceal the contents after preparation by a research pharmacist.","NA",null,"NA",null,"NA",null,"Y","A modified intention to treat approach was used ","NA",null,"Low","Low","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. Intention-to-treat analysis was performed. ",null,null,"Y","Data available for >95% of those randomised.","NA",null,"NA",null,"NA",null,"Low","Low","Data available for >95% of those randomised.\r\n\r\n\r\n",null,null,"N","RDS based on clinical diagnosis, chest xray findings and oxygen therapy. ","N",null,"PN","The treatment was masked and outcome assessors were blinded. ","NA",null,"NA",null,"Low","Low","RDS was based on clinical diagnosis, chest xray findings and oxygen therapy. \r\n\r\nThe treatment was masked and outcome assessors were blinded. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ","N","Outcome and timeframe were prespecified","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. \r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 12.50","GAR2009A8","AW&CM","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Chronic Lung disease","Bronchopulmonary dysplasia","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Conference abstract(s) about the trial","Y","Y","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence.","N","No marked imbalance of baseline characteristics. ","Low","Low","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","Normal saline placebo was used. The study syringes (betamethasone or saline) were completely covered by a label to conceal the contents after preparation by a research pharmacist.","NA",null,"NA",null,"NA",null,"Y","A modified intention to treat approach was used ","NA",null,"Low","Low","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. Intention-to-treat analysis was performed. ",null,null,"Y","Data available for >95% of those randomised.","NA",null,"NA",null,"NA",null,"Low","Low","Data available for >95% of those randomised.\r\n\r\n\r\n",null,null,"PN","Chronic lung disease was based on oxygen therapy at 30 days after birth. The treatment was masked and outcome assessors were blinded. ","PN",null,"PN","The treatment was masked and outcome assessors were blinded. ","NA",null,"NA",null,"Low","Low","Chronic lung disease was based on oxygen therapy at 30 days after birth. The treatment was masked and outcome assessors were blinded. \r\n\r\nThe treatment was masked and outcome assessors were blinded. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ","N","Outcome and timeframe were prespecified","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 12.51","GAR2009A9","AW&CM","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Severe IVH","Severe IVH","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Conference abstract(s) about the trial","Y","Y","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence.","N","No marked imbalance of baseline characteristics. ","Low","Low","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","Normal saline placebo was used. The study syringes (betamethasone or saline) were completely covered by a label to conceal the contents after preparation by a research pharmacist.","NA",null,"NA",null,"NA",null,"Y","A modified intention to treat approach was used ","NA",null,"Low","Low","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. Intention-to-treat analysis was performed. ",null,null,"Y","Data available for 95% of those randomised.","NA",null,"NA",null,"NA",null,"Low","Low","Data available for 95% of those randomised.\r\n\r\n\r\n",null,null,"PN","Outcome measurement method not stated but unlikely to have differed between treatment groups. ","PN",null,"PN","The treatment was masked and outcome assessors were blinded. ","NA",null,"NA",null,"Low","Low","Outcome measurement method not stated but unlikely to have differed between treatment groups. \r\n\r\nThe treatment was masked and outcome assessors were blinded. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ","N","Outcome and timeframe were prespecified.","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. \r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 12.51","GAR2009A10","AW&CM","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","IVH","IVH","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Conference abstract(s) about the trial","Y","Y","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence.","N","No marked imbalance of baseline characteristics. ","Low","Low","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","Normal saline placebo was used. The study syringes (betamethasone or saline) were completely covered by a label to conceal the contents after preparation by a research pharmacist.","NA",null,"NA",null,"NA",null,"Y","A modified intention to treat approach was used ","NA",null,"Low","Low","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. Intention-to-treat analysis was performed. ",null,null,"Y","Data available for 95% of those randomised.","NA",null,"NA",null,"NA",null,"Low","Low","Data available for 95% of those randomised.\r\n\r\n\r\n",null,null,"PN","Outcome measurement method not stated but unlikely to have differed between treatment groups. ","PN",null,"PN","The treatment was masked and outcome assessors were blinded. ","NA",null,"NA",null,"Low","Low","Outcome measurement method not stated but unlikely to have differed between treatment groups. \r\n\r\nThe treatment was masked and outcome assessors were blinded. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ","N","Outcome and timeframe were prespecified.","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. \r\n",null,null,"Low","Low","Low risk of bias for all domains. \r\n\r\n"]
["2022/01/14 12.51","GAR2009A11","AW&CM","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Necrotizing enterocolitis","Necrotizing enterocolitis","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Conference abstract(s) about the trial","Y","Y","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence.","N","No marked imbalance of baseline characteristics. ","Low","Low","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","Normal saline placebo was used. The study syringes (betamethasone or saline) were completely covered by a label to conceal the contents after preparation by a research pharmacist.","NA",null,"NA",null,"NA",null,"Y","A modified intention to treat approach was used ","NA",null,"Low","Low","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. Intention-to-treat analysis was performed. ",null,null,"Y","Data available for >95% of those randomised.","NA",null,"NA",null,"NA",null,"Low","Low","Data available for >95% of those randomised.\r\n\r\n\r\n",null,null,"NI","The definition used for a diagnosis of NEC was not clear in the study report or protocol. ","PN",null,"N","The treatment was masked and outcome assessors were blinded. ","NA",null,"NA",null,"Low","Low","The definition of NEC was not clear in the report but the treatment was masked and outcome assessors were blinded so ascertainment is unlikely to have differed between groups. ",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ","PN","Outcome and timeframe were prespecified.","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Low","Low","Low risk of bias for all domains. \r\n\r\n"]
["2022/01/14 12.51","GAR2009A12","AW&CM","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Composite serious outcome ","Composite neonatal morbidity","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Conference abstract(s) about the trial","Y","Y","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence.","N","No marked imbalance of baseline characteristics. ","Low","Low","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","Normal saline placebo was used. The study syringes (betamethasone or saline) were completely covered by a label to conceal the contents after preparation by a research pharmacist.","NA",null,"NA",null,"NA",null,"Y","A modified intention to treat approach was used ","NA",null,"Low","Low","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. Intention-to-treat analysis was performed. ",null,null,"Y","Data available for >95% of those randomised.","NA",null,"NA",null,"NA",null,"Low","Low","Data available for >95% of those randomised.\r\n\r\n\r\n",null,null,"PN","The composite components were clearly defined but methods of measurement of components were not all stated. ","PN",null,"N","The treatment was masked and outcome assessors were blinded. ","NA",null,"NA",null,"Low","Low","The composite components were clearly defined but methods of measurement of components were not all stated. \r\n\r\nThe treatment was masked and outcome assessors were blinded. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ","PN","Outcome and timeframe were prespecified.","N",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 12.55","GAR2009F1III","AW&CM","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Gestational age at birth","Gestational age at birth <34 weeks","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Conference abstract(s) about the trial","Y","Y","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence.","N","No marked imbalance of baseline characteristics. ","Low","Low","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","Normal saline placebo was used. The study syringes (betamethasone or saline) were completely covered by a label to conceal the contents after preparation by a research pharmacist.","NA",null,"NA",null,"NA",null,"Y","A modified intention to treat approach was used ","NA",null,"Low","Low","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. Intention-to-treat analysis was performed. ",null,null,"Y","Data available for >95% of those randomised.","NA",null,"NA",null,"NA",null,"Low","Low","Data available for >95% of those randomised.\r\n\r\n\r\n",null,null,"N",null,"N","Assessment method for gestational age not stated. Likely to have followed standard methods and unlikely to have differed between groups. ","N","The treatment was masked and outcome assessors were blinded. ","NA",null,"NA",null,"Low","Low","Assessment method for gestational age not stated. Likely to have followed standard methods and unlikely to have differed between groups. The treatment was masked and outcome assessors were blinded. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ","N","Outcome prespecified. ","N",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 12.55","GAR2009F1V","AW&CM","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","gestational age at birth","mean gestational age at birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Conference abstract(s) about the trial","Y","Y","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence.","N","No marked imbalance of baseline characteristics. ","Low","Low","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","Normal saline placebo was used. The study syringes (betamethasone or saline) were completely covered by a label to conceal the contents after preparation by a research pharmacist.","NA",null,"NA",null,"NA",null,"Y","A modified intention to treat approach was used ","NA",null,"Low","Low","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. Intention-to-treat analysis was performed. ",null,null,"Y","Data available for >95% of those randomised.","NA",null,"NA",null,"NA",null,"Low","Low","Data available for >95% of those randomised.\r\n\r\n\r\n",null,null,"N",null,"N","Assessment method for gestational age not stated. Likely to have followed standard methods and unlikely to have differed between groups. ","N","The treatment was masked and outcome assessors were blinded. ","NA",null,"NA",null,"Low","Low","Assessment method for gestational age not stated. Likely to have followed standard methods and unlikely to have differed between groups. The treatment was masked and outcome assessors were blinded. \r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ","N","Outcome prespecified. ","N",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 12.55","GAR2009F2","AW&CM","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Small for gestational age","\"IUGR\" defined as <10th centile for weight at birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Conference abstract(s) about the trial","Y","Y","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence.","N","No marked imbalance of baseline characteristics. ","Low","Low","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","Normal saline placebo was used. The study syringes (betamethasone or saline) were completely covered by a label to conceal the contents after preparation by a research pharmacist.","NA",null,"NA",null,"NA",null,"Y","A modified intention to treat approach was used ","NA",null,"Low","Low","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. Intention-to-treat analysis was performed. ",null,null,"Y","Data available for >95% of those randomised.","NA",null,"NA",null,"NA",null,"Low","Low","Data available for >95% of those randomised.\r\n\r\n\r\n",null,null,"N",null,"N",null,"N","The treatment was masked and outcome assessors were blinded. ","NA",null,"NA",null,"Low","Low","\r\n\r\nOutcome assessors were blinded as noted in protocol. \r\n\r\n",null,null,"PY","Trial registration document had prespecified outcomes and power calculations. An interim analysis was performed. ","PN","Outcome classification as birthweight <10th centile was prespecified.","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. \r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 12.56","GAR2009F4","AW&CM","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Proven neonatal infection in NICU","Blood culture proven sepsis","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Conference abstract(s) about the trial","Y","Y","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence.","N","No marked imbalance of baseline characteristics. ","Low","Low","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","Normal saline placebo was used. The study syringes (betamethasone or saline) were completely covered by a label to conceal the contents after preparation by a research pharmacist.","NA",null,"NA",null,"NA",null,"Y","A modified intention to treat approach was used ","NA",null,"Low","Low","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. Intention-to-treat analysis was performed. ",null,null,"Y","Data available for >95% of those randomised.","NA",null,"NA",null,"NA",null,"Low","Low","Data available for >95% of those randomised.\r\n\r\n\r\n",null,null,"N","Diagnosis of this outcome required positive blood cultures, making it more objective than pure clinical diagnosis. ","PN",null,"N","The treatment was masked and outcome assessors were blinded. ","NA",null,"NA",null,"Low","Low","Diagnosis of this outcome required positive blood cultures, making it more objective than pure clinical diagnosis. The treatment was masked and outcome assessors were blinded. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ","PN","Outcome and timeframe was prespecified but not how sepsis was defined. ","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 12.57","GAR2009F7","AW&CM","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Retinopathy of prematurity","Retinopathy of prematurity","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Conference abstract(s) about the trial","Y","Y","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence.","N","No marked imbalance of baseline characteristics. ","Low","Low","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","Normal saline placebo was used. The study syringes (betamethasone or saline) were completely covered by a label to conceal the contents after preparation by a research pharmacist.","NA",null,"NA",null,"NA",null,"Y","A modified intention to treat approach was used ","NA",null,"Low","Low","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. Intention-to-treat analysis was performed. ",null,null,"Y","Data available for 91% of those randomised.","NA",null,"NA",null,"NA",null,"Low","Low","Data available for 91% of those randomised.\r\n\r\n\r\n",null,null,"NI","The method of assessment was not identified in the methods or protocol.","PN","Method of assessment not detailed. ","N","The treatment was masked and outcome assessors were blinded. ","NA",null,"NA",null,"Low","Low","The method of assessment was not identified in the methods or protocol.\r\nMethod of assessment not detailed. \r\nThe treatment was masked and outcome assessors were blinded. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was not specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ","PN","The time point of assessment was unclear and this outcome was not in the methods or registration document. ","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was not specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. \r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 12.57","GAR2009F8","AW&CM","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Periventricular leukomalacia","Periventricular leukomalacia","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Conference abstract(s) about the trial","Y","Y","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence.","N","No marked imbalance of baseline characteristics. ","Low","Low","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","Normal saline placebo was used. The study syringes (betamethasone or saline) were completely covered by a label to conceal the contents after preparation by a research pharmacist.","NA",null,"NA",null,"NA",null,"Y","A modified intention to treat approach was used ","NA",null,"Low","Low","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. Intention-to-treat analysis was performed. ",null,null,"Y","Data available for 94% of those randomised.","NA",null,"NA",null,"NA",null,"Low","Low","Data available for 94% of those randomised.\r\n\r\n\r\n",null,null,"PN","The method of assessment was not identified in the methods or protocol but was unlikely to have differed between treatment groups.","PN",null,"N","The treatment was masked and outcome assessors were blinded. ","NA",null,"NA",null,"Low","Low","The method of assessment was not identified in the methods or protocol but was unlikely to have differed between treatment groups.\r\n\r\nThe treatment was masked and outcome assessors were blinded. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ","N","Outcome and timeframe was prespecified.","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. \r\nOutcome and timeframe was prespecified.\r\n",null,null,"Low","Low","Low risk of bias for all domains. \r\n\r\n"]
["2022/01/14 12.57","GAR2009F12","AW&CM","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Use of invasive respiratory support ","\"ventilator\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Conference abstract(s) about the trial","Y","Y","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence.","N","No marked imbalance of baseline characteristics. ","Low","Low","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","Normal saline placebo was used. The study syringes (betamethasone or saline) were completely covered by a label to conceal the contents after preparation by a research pharmacist.","NA",null,"NA",null,"NA",null,"Y","A modified intention to treat approach was used ","NA",null,"Low","Low","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. Intention-to-treat analysis was performed. ",null,null,"Y","Data available for 94% of those randomised.","NA",null,"NA",null,"NA",null,"Low","Low","Data available for 94% of those randomised.\r\n\r\n\r\n",null,null,"N","Based on treatment administered by clinical team. Unlikely to have differed between treatment groups. ","PN",null,"N","The treatment was masked and outcome assessors were blinded. ","NA",null,"NA",null,"Low","Low","Based on treatment administered by clinical team. Unlikely to have differed between treatment groups. \r\n\r\nThe treatment was masked and outcome assessors were blinded. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ","N","Timing of outcome assessment was prespecified.","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. \r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 12.58","GAR2009F15","AW&CM","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Use of surfactant","Use of surfactant","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Conference abstract(s) about the trial","Y","Y","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence.","N","No marked imbalance of baseline characteristics. ","Low","Low","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","Normal saline placebo was used. The study syringes (betamethasone or saline) were completely covered by a label to conceal the contents after preparation by a research pharmacist.","NA",null,"NA",null,"NA",null,"Y","A modified intention to treat approach was used ","NA",null,"Low","Low","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. Intention-to-treat analysis was performed. ",null,null,"Y","Data available for >95% of those randomised.","NA",null,"NA",null,"NA",null,"Low","Low","Data available for >95% of those randomised.\r\n\r\n\r\n",null,null,"N","Measurement based on treatment administered by clinical team. Unlikely to have differed between treatment groups. ","PN",null,"N","The treatment was masked and outcome assessors were blinded. ","NA",null,"NA",null,"Low","Low","Measurement based on treatment administered by clinical team. Unlikely to have differed between treatment groups. The treatment was masked and outcome assessors were blinded. \r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ","N","Outcome timeframe was specified and the outcome definition was prespecified.","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 13.03","GAR2009F18","AW&CM","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Air leak syndrome","pneumothorax","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Conference abstract(s) about the trial","Y","Y","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence.","N","No marked imbalance of baseline characteristics. ","Low","Low","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","Normal saline placebo was used. The study syringes (betamethasone or saline) were completely covered by a label to conceal the contents after preparation by a research pharmacist.","NA",null,"NA",null,"NA",null,"Y","A modified intention to treat approach was used ","NA",null,"Low","Low","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. Intention-to-treat analysis was performed. ",null,null,"Y","Data available for >95% of those randomised.","NA",null,"NA",null,"NA",null,"Low","Low","Data available for >95% of those randomised.\r\n\r\n\r\n",null,null,"N","Measurement was based on clinical diagnosis by the treating team ","PN",null,"N","The treatment was masked and outcome assessors were blinded. ","NA",null,"NA",null,"Low","Low","Measurement was based on clinical diagnosis by the treating team and was unlikely to have differed between treatment groups as the treatment was masked and outcome assessors were blinded. \r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ","N","Outcome and timing was prespecified. ","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. \r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 13.03","GAR2009F21","AW&CM","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Apgar score less than seven at five minutes","Apgar score less than seven at five minutes","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Conference abstract(s) about the trial","Y","Y","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence.","N","No marked imbalance of baseline characteristics. ","Low","Low","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","Normal saline placebo was used. The study syringes (betamethasone or saline) were completely covered by a label to conceal the contents after preparation by a research pharmacist.","NA",null,"NA",null,"NA",null,"Y","A modified intention to treat approach was used ","NA",null,"Low","Low","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. Intention-to-treat analysis was performed. ",null,null,"Y","Data available for >95% of those randomised.","NA",null,"NA",null,"NA",null,"Low","Low","Data available for >95% of those randomised.\r\n\r\n\r\n",null,null,"N","Measurement of APGAR scores are standard and would not have differed between treatment groups. ","PN",null,"N","The treatment was masked and outcome assessors were blinded. ","NA",null,"NA",null,"Low","Low","Measurement of APGAR scores are standard and would not have differed between treatment groups. The treatment was masked and outcome assessors were blinded. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was not specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ","N","Although not prespecified, this outcome is routinely collected data that was reported using a standard cut-off of <7. ","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was not specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. Although not prespecified, this outcome is routinely collected data that was reported using a standard cut-off of <7. \r\n","NA",null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 13.09","GAR2009L1","AW&CM","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Birthweight","Mean birthweight","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Conference abstract(s) about the trial","Y","Y","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence.","N","No marked imbalance of baseline characteristics. ","Low","Low","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","Normal saline placebo was used. The study syringes (betamethasone or saline) were completely covered by a label to conceal the contents after preparation by a research pharmacist.","NA",null,"NA",null,"NA",null,"Y","A modified intention to treat approach was used ","NA",null,"Low","Low","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. Intention-to-treat analysis was performed. ",null,null,"Y","Data available for >95% of those randomised.","NA",null,"NA",null,"NA",null,"Low","Low","Data available for >95% of those randomised.\r\n\r\n\r\n",null,null,"N","Measurement method unlikely to have differed between treatment groups. ","N",null,"N","The treatment was masked and outcome assessors were blinded. ","NA",null,"NA",null,"Low","Low","Measurement method unlikely to have differed between treatment groups. \r\n\r\nThe treatment was masked and outcome assessors were blinded. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ","N","Definition and timepoint were prespecified. ","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 13.09","GAR2009L3","AW&CM","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Head circumference at birth","Head circumference at birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Conference abstract(s) about the trial","Y","Y","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence.","N","No marked imbalance of baseline characteristics. ","Low","Low","A blocked randomisation sequence was used that was prepared centrally. The random sequence was generated by computer.\r\nThe research pharmacist (unblinded) at each site prepared the medication based on the blocked randomisation sequence. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","Normal saline placebo was used. The study syringes (betamethasone or saline) were completely covered by a label to conceal the contents after preparation by a research pharmacist.","NA",null,"NA",null,"NA",null,"Y","A modified intention to treat approach was used ","NA",null,"Low","Low","The injection of the study treatment was given by a designated research nurse who was not caring for the woman. The physical appearance of the study solutions was masked. Intention-to-treat analysis was performed. ",null,null,"Y","Data available for >95% of those randomised.","NA",null,"NA",null,"NA",null,"Low","Low","Data available for >95% of those randomised.\r\n\r\n\r\n",null,null,"N","Measurement method unlikely to have differed between treatment groups. ","N",null,"N","The treatment was masked and outcome assessors were blinded. ","NA",null,"NA",null,"Low","Low","Measurement method unlikely to have differed between treatment groups. \r\n\r\nThe treatment was masked and outcome assessors were blinded. \r\n\r\n",null,null,"PY","Trial registration document had prespecified outcomes and power calculations. An interim analysis was performed. ","N","Definition and timepoint were prespecified. ","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration documentation. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 10.46","CRO2006A1","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Fetal or neonatal or infant death","Stillbirth + neonatal death","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N","Outcome measure was objective. ","N",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Outcome measure was objective. \r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N","Objective outcome and clearly defined timepoint. ","N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 10.49","CRO2006A2","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Fetal death","Stillbirth","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N","Outcome measure was objective. ","N",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Outcome measure was objective. \r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N","Objective outcome and clearly defined timepoint. ","N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 10.49","CRO2006A3","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Neonatal death","death before initial discharge home. ","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N","Outcome measure was objective. ","N",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Outcome measure was objective. \r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N","Objective outcome and clearly defined timepoint. ","N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 10.58","CRO2006A5","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","RDS","RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N","Definition clearly stated in methods. Outcome was as per the diagnosis from case notes and defined by clinical and radiological features. ","N","Prespecified outcome","N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Outcome was as per the diagnosis from case notes and defined by clinical and radiological features. Outcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The primary outcome was specified in the trial registration document as neonatal respiratory outcomes. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N","Absolute numbers of events were recorded. ","Low","Low","Methods state prespecified analysis. The primary outcome was specified in the trial registration document as neonatal respiratory outcomes. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 10.58","CRO2006A7","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Severe lung disease","severe lung disease","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N","Definition clearly stated in methods. Severity of lung disease classified using defined thresholds. ","N","Prespecified outcome","N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Severity of lung disease classified using defined thresholds. Outcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The primary outcome was specified in the trial registration document as neonatal respiratory outcomes. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N","Absolute numbers of events were recorded. ","Low","Low","Methods state prespecified analysis. The primary outcome was specified in the trial registration document as neonatal respiratory outcomes. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 10.58","CRO2006A8","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","chronic lung disease","Oxygen requirement at 36weeks post conception","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N","Definition clearly stated in methods. ","N","Prespecified outcome. Defined by need for a clinical treatment. Unlikely to have differed by group due to blinding of clinical team. ","N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Definition clearly stated in methods. \r\nPrespecified outcome. Defined by need for a clinical treatment. Unlikely to have differed by group due to blinding of clinical team. \r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N","Absolute numbers of events are recorded. ","Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 10.58","CRO2006A9","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","severe IVH","Grade 3 or 4 IVH, RR 0.64","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"PN","Information on this diagnosis was obtained from case notes. ","PN",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Information on this diagnosis was obtained from case notes. \r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N","Absolute numbers of events are recorded. ","Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 10.58","CRO2006A10","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","IVH","IVH RR 0.86 in original trial publication. ","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"PN","Information on this diagnosis was obtained from case notes. ","PN",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Information on this diagnosis was obtained from case notes. \r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis but statistical analysis plan not available to review. ","N",null,"N","Absolute numbers of events are recorded. ","Low","Low","Methods state prespecified analysis but statistical analysis plan not available to review. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 10.59","CRO2006A11","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","NEC","RR 0.47, \"Proven necrotizing enterocolitis\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"PN","Information on this diagnosis was obtained from case notes. ","PN",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Information on this diagnosis was obtained from case notes. \r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N","Absolute numbers of events are recorded. ","Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.03","CRO2006A12","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Composite serious outcome","RR 0.79, \"Other serious neonatal morbidity\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"PN","The individual components of the composite were obtained from case notes and ascertainment is unlikely to have differed between treatment groups.","PN",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","The individual components of the composite were obtained from case notes and ascertainment is unlikely to have differed between treatment groups.\r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state outcome was post hoc. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","PN","The components do appear to include all relevant reported outcomes for this composite. ","N","Absolute numbers of events are recorded. ","Low","Low","Methods state outcome was post hoc. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.06","CRO2006F1","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Gestational age at birth","mean gestational age at birth, >37 weeks, <37 weeks, <34 weeks, <28 weeks","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N","Method of gestational age assessment not stated but unlikely to have differed between treatment groups. ","N",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Method of gestational age assessment not stated but unlikely to have differed between treatment groups. \r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N","Absolute numbers of events are recorded for categorical data. Continuous reported as mean and SD as per methods. ","Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.07","CRO2006F3","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Admission to NICU","Admission to NICU, RR 1.05","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N","Outcome based on clinical course, obtained from case notes. ","N",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Outcome based on clinical course, obtained from case notes. \r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N","Timepoint of assessments prespecified. Outcome can only be measured in one way. ","N","Absolute numbers of events are recorded. ","Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.07","CRO2006F4","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Proven neonatal infection while in NICU","\"Any proven infection\", RR 0.98","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N","Outcome measurement based on information in case notes. ","N",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Outcome measurement based on information in case notes. \r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","PN",null,"N","Absolute numbers of events are recorded. ","Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.07","CRO2006F5","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Early systemic neonatal infection(<48 hours after birth)","\"systemic infection suspected <48hours after birth), RR 1.00","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N","Outcome measurement based on information in case notes. ","N",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Outcome measurement based on information in case notes. \r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","PN",null,"N","Absolute numbers of events are recorded. ","Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.07","CRO2006F7","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","ROP","ROP, RR 0.94","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"NI","The method of measurement of retinopathy of prematurity was not specified.","N",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","The method of measurement of retinopathy of prematurity was not specified but was unlikely to have differed between treatment groups.\r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","PN","Timeframe of assessments was clearly defined. ","N","Absolute numbers of events are recorded. ","Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.07","CRO2006F8","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","PVL","PVL, RR 0.53","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"PN","The cranial imaging was done as per usual clinical care. ","PN",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Cranial imaging was performed as per usual clinical care. Definition of PVL not specified. Outcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N","Timeframe of assessment clearly defined.  ","N","Absolute numbers of events are recorded. ","Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.07","CRO2006F10","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","PDA","PDA, RR 0.59","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"PN","Outcome was based on diagnosis of PDA stated in the case notes.","PN",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Outcome was based on diagnosis of PDA stated in the case notes.\r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N","Timeframe of assessment was clear. ","N","Absolute numbers of events are recorded. ","Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.08","CRO2006F12","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Use of invasive respiratory support","\"use of mechanical ventilation\", RR 0.87","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N","Measurement based on treatment administered by clinical team. Unlikely to have differed between treatment groups. ","N",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","\r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N","Absolute numbers of events are recorded. ","Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.09","CRO2006F14","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Use of oxygen supplementation","\"use of oxygen therapy\", RR 0.90","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N","Measurement based on treatment administered by clinical team. Unlikely to have differed between treatment groups. ","PN",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Measurement based on treatment administered by clinical team. Unlikely to have differed between treatment groups. \r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N",null,"N","Absolute numbers of events are recorded. ","Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.09","CRO2006F15","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Use of surfactant","Use of surfactant, rr 0.81","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N","Measurement based on treatment administered by clinical team. Unlikely to have differed between treatment groups. ","PN",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Measurement based on treatment administered by clinical team. Unlikely to have differed between treatment groups. \r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N","Timepoint of assessment stated. ","N","Absolute numbers of events are recorded. ","Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.09","CRO2006F16","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Use of nitric oxide for respiratory support","Use of nitric oxide for respiratory support, rr  0.60","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N","Measurement based on treatment administered by clinical team. Unlikely to have differed between treatment groups. ","PN",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Measurement based on treatment administered by clinical team. Unlikely to have differed between treatment groups. \r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N","Timepoint of assessment stated. ","N","Absolute numbers of events are recorded. ","Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.09","CRO2006F17","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Use of postnatal corticosteroids","\"use of steroids postnatally\", rr 1.39","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N","Measurement based on treatment administered by clinical team. Unlikely to have differed between treatment groups. ","PN",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Measurement based on treatment administered by clinical team. Unlikely to have differed between treatment groups. \r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N","Timepoint of assessment stated. ","N","Absolute numbers of events are recorded. ","Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.09","CRO2006F18","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","air leak syndrome","air leak syndrome, rr 1.1","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"PN","Outcome was based on diagnosis of air leak syndrome stated in the case notes. ","PN",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Outcome was based on diagnosis of air leak syndrome stated in the case notes. \r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N","Timepoint of assessment stated. ","N","Absolute numbers of events are recorded. ","Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.09","CRO2006F20","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Use of inotropic support","Use of inotropic support, rr 0.75","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N","Measurement based on treatment administered by clinical team. Unlikely to have differed between treatment groups. ","N",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Measurement based on treatment administered by clinical team. Unlikely to have differed between treatment groups. \r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N","Timepoint of assessment defined as <28days. ","N","Absolute numbers of events are recorded. ","Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.09","CRO2006F21","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Apgar score <7 at 5 minutes","Apgar score <7 at 5 minutes, rr 0.92","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N","Measurement of APGAR scores are standard and would not have differed between treatment groups. ","N",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Measurement of APGAR scores are standard and would not have differed between treatment groups. \r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N","Only this specific Apgar score timepoint and cut-off point is eligible for inclusion. ","N","Absolute numbers of events are recorded. ","Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.09","CRO2006F22","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Cardiac hypertrophy ","thickness of IVS or LVPW in mm. ","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"N","Assessment of this outcome was only performed at one centre. Consent obtained for 145 (of 189 randomised at this centre) prior to birth. ","N","Missing data was noted as due to unsuccessful measurements. ","PY","Amount of missing data differed between groups (26% and 20% in intervention and placebo group) ","PN",null,"Some concerns","Some concerns","Assessment of this outcome was only performed at one centre. Consent obtained for 145 (of 189 randomised at this centre) prior to birth.  Missing data was noted as due to unsuccessful measurement and differed between groups (26% and 20% in intervention and placebo group).",null,null,"N","Standard measurements of septum and left ventricular wall by cardiac echocardiography. ","PN",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Standard measurements of septum and left ventricular wall obtained by cardiac echocardiography. \r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N","Timepoint of assessment stated. All measures stated in methods were reported in results. ","N","Continuous outcome was reported as mean and SD, consistent with methods section. ","Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Some concerns","Some concerns","Some concerns of missing outcome data because the proportion of missing data differed between groups."]
["2022/01/14 11.10","CRO2006L1","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Birthweight","birthweight, z scores","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N",null,"N",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Outcome measurement unlikely to have differed between treatment groups as outcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"Y","Methods state prespecified analysis. The outcome was specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N","Timepoint of assessment clearly defined. ","N",null,"Low","Low","Methods state prespecified analysis. The outcome was specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.10","CRO2006L3","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Head circumference at birth","Head circumference at birth and z scores","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N",null,"N",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","\r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"Y","Methods state prespecified analysis. The outcome was specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N","Timepoint of assessment clearly defined. ","N",null,"Low","Low","Methods state prespecified analysis. The outcome was specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.10","CRO2006L4","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Length at birth ","Length at birth and z scores","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N",null,"N",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Outcome measurement unlikely to have differed between treatment groups as outcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"Y","Methods state prespecified analysis. The outcome was specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N","Timepoint of assessment clearly defined. ","N",null,"Low","Low","Methods state prespecified analysis. The outcome was specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.32","CRO2006L5I","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","weight at primary hospital discharge","weight at discharge, z scores","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N",null,"N",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Outcome measurement unlikely to have differed between treatment groups as outcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"Y","Methods state prespecified analysis. The outcome was specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N","Timepoint of assessment clearly defined. ","N",null,"Low","Low","Methods state prespecified analysis. The outcome was specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.11","CRO2006L5II","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","head circumference  at primary hospital discharge","HC at discharge, z scores ","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N",null,"N",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Outcome measurement unlikely to have differed between treatment groups as outcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"Y","Methods state prespecified analysis. The outcome was specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N","Timepoint of assessment clearly defined. ","N",null,"Low","Low","Methods state prespecified analysis. The outcome was specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.11","CRO2006L5III","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","length at primary hospital discharge","length at discharge, z scores","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N",null,"N",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Outcome measurement unlikely to have differed between treatment groups as outcome assessors were blinded to treatment allocation.  \r\n\r\n",null,null,"Y","Methods state prespecified analysis. The outcome was specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N","Timepoint of assessment clearly defined. ","N",null,"Low","Low","Methods state prespecified analysis. The outcome was specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.13","CRO2006L8","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Duration or invasive respiratory support","calculated mean and SD for duration of mechanical ventilation","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N","Outcome based on care administered by treating team as per case notes.","PN",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Outcome based on care administered by treating team as per case notes.\r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N","Timepoint of assessment stated.  ","N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.13","CRO2006L10","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Duration of oxygen supplementation","calculated mean and SD from \"duration of oxygen therapy\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N","Outcome based on care administered by treating team as per case notes.","PN",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Outcome based on care administered by treating team as per case notes.\r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N","Timepoint of assessment stated. ","N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 11.13","CRO2006L14I","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Measures of HPA axis function","Birth cord serum cortisol, Women at the Women’s and Children’s Hospital, Adelaide","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"PN","67/102 infants randomised at this site had cord blood available. ","N",null,"PY","Reasons for missing data noted as insufficient sample, \"missed\" or infants not born at this site. ","PN",null,"Some concerns","Some concerns","67/102 infants randomised at this site had cord blood available. \r\n\r\nReasons for missing data noted as insufficient sample, \"missed\" or infants not born at this site. \r\n",null,null,"PY","Cord cortisol is a poor measure of HPA axis.","N",null,"NA",null,"NA",null,"NA",null,"High","Some concerns","Outcome assessors were blinded to allocation. Measurement of cord cortisol is not a reliable measure of HPA axis function.\r\n\r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","PN","All expected timepoints were reported. ","PN","Results described using mean and SD","Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Some concerns","Some concerns","Some concerns due to missing outcome data and those assessed were only from one site. Measurement of cord cortisol is not a reliable measure of HPA axis function."]
["2022/01/14 11.13","CRO2006L14II","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Measures of HPA axis function","Day 3,7,14,21 basal salivary cortisol, Babies at Women’s and Children’s Hospital, Adelaide","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"PN","Saliva was collected from 50% infants randomised at this site. Samples reduced in number over the 21 day study period due to infants being discharged. ","N",null,"PY","It is possible that missing data could relate to how unwell the child is at the time of testing and missing data differed between groups.  ","PN",null,"High","High","Saliva was collected from 50% infants randomised at this site. Samples reduced in number over the 21 day study period due to infants being discharged. \r\n\r\nIt is possible that missing data could relate to how unwell the child is at the time of testing and missing data differed between groups.  \r\n",null,null,"N","Baseline testing of HPA axis function was an appropriate assessment in conjunction with dynamic testing and unlikely to have differed in its ascertainment between groups. ","N",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Baseline testing of HPA axis function was an appropriate assessment in conjunction with dynamic testing and unlikely to have differed in its ascertainment between groups. \r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","PN",null,"PN","Results described using simple descriptive statistics (median and IQR)","Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"High","High","Saliva was collected from 50% infants randomised at this site. Samples reduced in number over the 21 day study period due to infants being discharged. \r\n\r\nIt is possible that missing data could relate to how unwell the child is at the time of testing and missing data differed between groups.  "]
["2022/01/14 11.13","CRO2006L14III","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Measures of HPA axis function","Post stress day 3 salivary cortisol, Babies at Women’s and Children’s Hospital, Adelaide","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"PN","Post stress samples were only available for 27 infants (26% of those randomised at this site). ","N",null,"PY","It is possible that missing data could relate to how unwell the child is at the time of testing.","PN",null,"High","High","Post stress samples were only available for 27 infants (26% of those randomised at this site). \r\n\r\n\r\n",null,null,"N","Dynamic testing of HPA axis function was an appropriate assessment and unlikely to have differed in its ascertainment between groups. ","N",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Dynamic testing of HPA axis function was an appropriate assessment and unlikely to have differed in its ascertainment between groups. \r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","PN",null,"PN","Results described using simple descriptive statistics (median and IQR)","Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"High","High","Post stress samples were only available for 27 infants of 51 with salivary samples. \r\n"]
["2022/01/14 11.13","CRO2006L14IV","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Measures of HPA axis function","ACTH, Cortisol at baseline day 2-3 ","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"PN","This was a single site sub study of 63 infants whose parents consented prior to randomisation in the main study.  10 had a missing ACTH level but it is unclear to which group these belonged. ","PN",null,"PY",null,"PN",null,"Some concerns","Some concerns","This was a single site sub study of 63 infants whose parents consented prior to randomisation in the main study.  10 had a missing ACTH level but it is unclear to which group these belonged. ",null,null,"N","Baseline testing of HPA axis function was an appropriate assessment in conjunction with dynamic testing and unlikely to have differed in its ascertainment between groups. ","PN",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Baseline testing of HPA axis function was an appropriate assessment in conjunction with dynamic testing and unlikely to have differed in its ascertainment between groups. \r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","PN","Results consistent with plan in methods .","PN","Results described using simple descriptive statistics (median and IQR)","Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Some concerns","Some concerns","This was a single site sub study of 63 infants whose parents consented prior to randomisation in the main study.  10 had a missing ACTH level but it is unclear to which group these belonged. "]
["2022/01/14 11.13","CRO2006L14V","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Measures of HPA axis function","Post metyrapone ACTH, 11 deoxycortisol and cortisol","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"N","only 26/63(41%) infants in this sub study had post-metyrapone testing.","PN",null,"PY","Missing outcome data explained due to lack of consent for full post metyrapone testing of all infants. ","PN",null,"Some concerns","High","only 26/63(41%) infants in this sub study had post-metyrapone testing.\r\n\r\nMissing outcome data explained due to lack of consent for full post metyrapone testing of all infants. \r\n",null,null,"N","Dynamic testing of HPA axis function was an appropriate assessment and unlikely to have differed in its ascertainment between groups. ","PN",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Dynamic testing of HPA axis function was an appropriate assessment and unlikely to have differed in its ascertainment between groups. \r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","PN","Results consistent with plan in methods .","PN","Results described using simple descriptive statistics (median and IQR)","Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"High","High","only 26/63(41%) infants in this sub study had post-metyrapone testing.\r\n\r\nMissing outcome data explained due to lack of consent for full post metyrapone testing of all infants. "]
["2022/01/14 11.13","CRO2006Q4","AW&PM","Crowther 2006",2675226,"Betamethasone","Placebo","Length on infant hospitalisation ","\"length of hospital stay\", p value 0.66","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n","N","No marked imbalance of baseline characteristics. ","Low","Low","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. No marked imbalance of baseline characteristics. \r\n\r\n",null,null,"N","N","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention to treat. ","NA",null,"Low","Low","Treatment packs appeared identical with opaque syringes. Women and perinatal staff were blinded to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n",null,null,"Y","No missing data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. ",null,null,"N","Outcome ascertainment from case notes. ","PN",null,"N","Outcome assessors were blinded to treatment allocation. ","NA",null,"NA",null,"Low","Low","Outcome ascertainment from case notes. \r\n\r\nOutcome assessors were blinded to treatment allocation. \r\n\r\n",null,null,"PY","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.","N","Timepoint defined by outcome.","N",null,"Low","Low","Methods state prespecified analysis. The outcome was not specified in the trial registration document. Statistical analysis plan and protocol not available to review but outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 08.22","MCE2002F1","AW&JH","McEvoy 2002",2675252,"Betamethasone","Placebo","gestational age at birth","mean, term, preterm birth, ","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Allocation was performed by the pharmacy using a randomisation table. “The investigators and clinical care providers were unaware of the treatment provided and the placebo and intervention drug were noted to be identical in appearance. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Allocation was performed by the pharmacy using a randomisation table. The investigators and clinical care providers were unaware of the treatment provided and the placebo and intervention drug were noted to be identical in appearance. No marked imbalance of baseline characteristics. \r\n",null,null,"PN","N","Clinical care providers were unaware of allocation. The administered medication for placebo and intervention were identical in appearance. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat.","NA",null,"Low","Low","Clinical care providers were unaware of allocation. The administered medication for placebo and intervention were identical in appearance. \r\n\r\n\r\n\r\nAnalysis was by intention-to-treat.\r\n",null,null,"Y","No missing data for this outcome","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome\r\n\r\n\r\n",null,null,"N","Gestational age was calculated from last normal menstrual period and confirmed by Ballard examination. ","PN",null,"N","Investigators were unaware of allocation. ","NA",null,"NA",null,"Low","Low","Gestational age was calculated from last normal menstrual period and confirmed by Ballard examination. \r\n\r\nInvestigators were unaware of allocation. \r\n\r\n",null,null,"NI","No protocol, statistical analysis plan or registration document available for review. Outcome definition and analysis unlikely to have been selected based on results.","N",null,"PN","Absolute number of events reported and analysis well described in methods. ","Some concerns","Low","No protocol, statistical analysis plan or registration document available for review. Outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains."]
["2022/01/16 08.24","MCE2002F15","AW&JH","McEvoy 2002",2675252,"Betamethasone","Placebo","Use of surfactant","\"surfactant administration \"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Allocation was performed by the pharmacy using a randomisation table. “The investigators and clinical care providers were unaware of the treatment provided and the placebo and intervention drug were noted to be identical in appearance. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Allocation was performed by the pharmacy using a randomisation table. The investigators and clinical care providers were unaware of the treatment provided and the placebo and intervention drug were noted to be identical in appearance. No marked imbalance of baseline characteristics. \r\n",null,null,"PN","N","Clinical care providers were unaware of allocation. The administered medication for placebo and intervention were identical in appearance. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat.","NA",null,"Low","Low","Clinical care providers were unaware of allocation. The administered medication for placebo and intervention were identical in appearance. \r\n\r\n\r\n\r\nAnalysis was by intention-to-treat.\r\n",null,null,"Y","No missing data for this outcome","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome\r\n\r\n\r\n",null,null,"N","Outcome based on treatment administered by the treating team, who were blinded to allocation. ","PN",null,"N","Investigators were unaware of allocation. ",null,null,"NA",null,"Low","Low","Outcome based on treatment administered by the treating team, who were blinded to allocation. \r\n\r\nInvestigators were unaware of allocation. \r\n\r\n",null,null,"NI","No protocol, statistical analysis plan or registration document available for review. Outcome definition and analysis unlikely to have been selected based on results.","PN",null,"PN","limited alternative analyses","Some concerns","Low","No protocol, statistical analysis plan or registration document available for review. Outcome definition and analysis unlikely to have been selected based on results.\r\n\r\nlimited alternative analyses",null,null,"Low","Low","Low risk of bias for all domains."]
["2022/01/16 08.24","MCE2002L1","AW&JH","McEvoy 2002",2675252,"Betamethasone","Placebo","Birthweight","Birthweight mean and SD","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Allocation was performed by the pharmacy using a randomisation table. “The investigators and clinical care providers were unaware of the treatment provided and the placebo and intervention drug were noted to be identical in appearance. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Allocation was performed by the pharmacy using a randomisation table. The investigators and clinical care providers were unaware of the treatment provided and the placebo and intervention drug were noted to be identical in appearance. No marked imbalance of baseline characteristics. \r\n",null,null,"PN","N","Clinical care providers were unaware of allocation. The administered medication for placebo and intervention were identical in appearance. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat.","NA",null,"Low","Low","Clinical care providers were unaware of allocation. The administered medication for placebo and intervention were identical in appearance. \r\n\r\n\r\n\r\nAnalysis was by intention-to-treat.\r\n",null,null,"Y","No missing data for this outcome","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome\r\n\r\n\r\n",null,null,"N","Method of measurement not stated but likely to be standard and unlikely to have differed between groups.","N",null,"N","Investigators were unaware of allocation. ",null,null,"NA",null,"Low","Low","Method of measurement not stated but likely to be standard and unlikely to have differed between groups.\r\n\r\nInvestigators were unaware of allocation. \r\n\r\n",null,null,"NI","No protocol, statistical analysis plan or registration document available for review. Outcome definition and analysis unlikely to have been selected based on results.","N",null,"N","limited alternative analyses. ","Some concerns","Low","No protocol, statistical analysis plan or registration document available for review. Outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains."]
["2022/01/16 08.24","MCE2002L3","AW&JH","McEvoy 2002",2675252,"Betamethasone","Placebo","Head circumference at birth","\"Admission head circumference\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Allocation was performed by the pharmacy using a randomisation table. “The investigators and clinical care providers were unaware of the treatment provided and the placebo and intervention drug were noted to be identical in appearance. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Allocation was performed by the pharmacy using a randomisation table. The investigators and clinical care providers were unaware of the treatment provided and the placebo and intervention drug were noted to be identical in appearance. No marked imbalance of baseline characteristics. \r\n",null,null,"PN","N","Clinical care providers were unaware of allocation. The administered medication for placebo and intervention were identical in appearance. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat.","NA",null,"Low","Low","Clinical care providers were unaware of allocation. The administered medication for placebo and intervention were identical in appearance. \r\n\r\n\r\n\r\nAnalysis was by intention-to-treat.\r\n",null,null,"Y","No missing data for this outcome","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome\r\n\r\n\r\n",null,null,"N","Method of measurement not stated but likely to be standard and unlikely to have differed between groups.","PN",null,"N","Investigators were unaware of allocation. ",null,null,"NA",null,"Low","Low","Method of measurement not stated but likely to be standard and unlikely to have differed between groups.\r\n\r\nInvestigators were unaware of allocation. \r\n\r\n",null,null,"NI","No protocol, statistical analysis plan or registration document available for review. Outcome definition and analysis unlikely to have been selected based on results.","PN",null,"PN","This outcome has limited alternative analyses. ","Some concerns","Low","No protocol, statistical analysis plan or registration document available for review. Outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains."]
["2022/01/16 08.27","MCE2002L8","AW&JH","McEvoy 2002",2675252,"Betamethasone","Placebo","Duration of invasive respiratory support","days on IMV","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Allocation was performed by the pharmacy using a randomisation table. “The investigators and clinical care providers were unaware of the treatment provided and the placebo and intervention drug were noted to be identical in appearance. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Allocation was performed by the pharmacy using a randomisation table. The investigators and clinical care providers were unaware of the treatment provided and the placebo and intervention drug were noted to be identical in appearance. No marked imbalance of baseline characteristics. \r\n",null,null,"PN","N","Clinical care providers were unaware of allocation. The administered medication for placebo and intervention were identical in appearance. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat.","NA",null,"Low","Low","Clinical care providers were unaware of allocation. The administered medication for placebo and intervention were identical in appearance. \r\n\r\n\r\n\r\nAnalysis was by intention-to-treat.\r\n",null,null,"Y","No missing data for this outcome","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome\r\n\r\n\r\n",null,null,"N","Outcome based on treatment administered by the treating team, who were blinded to allocation. ","PN",null,"N","Investigators were unaware of allocation. ",null,null,"NA",null,"Low","Low","Outcome based on treatment administered by the treating team, who were blinded to allocation. \r\n\r\nInvestigators were unaware of allocation. \r\n\r\n",null,null,"NI","No protocol, statistical analysis plan or registration document available for review. Outcome definition and analysis unlikely to have been selected based on results.","PN",null,"PN","This outcome was reported as mean and SD and has limited alternative analyses. ","Some concerns","Low","No protocol, statistical analysis plan or registration document available for review. Outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains."]
["2022/01/16 08.26","MCE2002L10","AW&JH","McEvoy 2002",2675252,"Betamethasone","Placebo","Duration of oxygen supplementation","days on oxygen","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Allocation was performed by the pharmacy using a randomisation table. “The investigators and clinical care providers were unaware of the treatment provided and the placebo and intervention drug were noted to be identical in appearance. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Allocation was performed by the pharmacy using a randomisation table. The investigators and clinical care providers were unaware of the treatment provided and the placebo and intervention drug were noted to be identical in appearance. No marked imbalance of baseline characteristics. \r\n",null,null,"PN","N","Clinical care providers were unaware of allocation. The administered medication for placebo and intervention were identical in appearance. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat.","NA",null,"Low","Low","Clinical care providers were unaware of allocation. The administered medication for placebo and intervention were identical in appearance. \r\n\r\n\r\n\r\nAnalysis was by intention-to-treat.\r\n",null,null,"Y","No missing data for this outcome","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome",null,null,"N","Outcome based on treatment administered by the treating team, who were blinded to allocation. ","PN",null,"N","Investigators were unaware of allocation. ",null,null,"NA",null,"Low","Low","Outcome based on treatment administered by the treating team, who were blinded to allocation. \r\n\r\nInvestigators were unaware of allocation. \r\n\r\n",null,null,"NI","No protocol, statistical analysis plan or registration document available for review. Outcome definition and analysis unlikely to have been selected based on results.","PN",null,"PN","This outcome was reported as mean and SD and has limited alternative analyses. ","Some concerns","Low","No protocol, statistical analysis plan or registration document available for review. Outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains."]
["2022/01/16 08.26","MCE2002L14","AW&JH","McEvoy 2002",2675252,"Betamethasone","Placebo","Measures of HPA axis function","Basal cortisol and post ACTH stimulation cortisol\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Allocation was performed by the pharmacy using a randomisation table. “The investigators and clinical care providers were unaware of the treatment provided and the placebo and intervention drug were noted to be identical in appearance. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Allocation was performed by the pharmacy using a randomisation table. The investigators and clinical care providers were unaware of the treatment provided and the placebo and intervention drug were noted to be identical in appearance. No marked imbalance of baseline characteristics. \r\n",null,null,"PN","N","Clinical care providers were unaware of allocation. The administered medication for placebo and intervention were identical in appearance. ","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat.","NA",null,"Low","Low","Clinical care providers were unaware of allocation. The administered medication for placebo and intervention were identical in appearance. \r\n\r\n\r\n\r\nAnalysis was by intention-to-treat.\r\n",null,null,"N","11/37 participants had this outcome measured. It is unclear how many were in each allocation group. ","N",null,"PY","It is unclear how the subset studied for this outcome was chosen but it is possible that more unwell neonates may have been less likely to have been assessed for this outcome. ","NI",null,"High","High","11/37 participants had this outcome measured. It is unclear how many were in each allocation group. \r\n\r\nIt is unclear how the subset studied for this outcome was chosen but it is possible that more unwell neonates may have been less likely to have been assessed for this outcome. \r\n",null,null,"N","Dynamic testing with ACTH stimulation is appropriate for assessing suppression of HPA axis function. ","PN",null,"N","Investigators were unaware of allocation. ",null,null,"NA",null,"Low","Low","Dynamic testing with ACTH stimulation is appropriate for assessing suppression of HPA axis function. \r\n\r\nInvestigators were unaware of allocation. \r\n\r\n",null,null,"NI","No protocol, statistical analysis plan or registration document available for review. Outcome definition and analysis unlikely to have been selected based on results.","PN",null,"PN","This outcome has limited alternative analyses. ","Some concerns","Low","No protocol, statistical analysis plan or registration document available for review. Outcome definition and analysis unlikely to have been selected based on results.",null,null,"High","High","High risk overall due to high-risk of bias due to missing outcome data. 11/37 participants had this outcome measured. It is unclear how many were in each allocation group. It is unclear how the subset studied for this outcome was chosen but it is possible that more unwell neonates may have been less likely to have been assessed for this outcome. \r\n"]
["2022/01/14 15.20","GUI2002A1","AW&CC","Guinn 2002",2675243,"Betamethasone","Placebo","Fetal or neonatal or infant death","perinatal death","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre was used. The pharmacy then assigned participants to intervention or placebo groups. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat. ","NA",null,"Low","Low","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.\r\n\r\n\r\n\r\nAnalysis was by intention-to-treat. \r\n",null,null,"Y",">95% had data available for this outcome. \r\n\r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low",">95% had data available for this outcome. \r\n\r\n\r\n",null,null,"N","Outcome was objective. ","N",null,"NI","Data on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation. ","N","Assessment not able to be influenced by knowledge of allocation. ","NA",null,"Low","Low","Outcome was objective. \r\n\r\nData on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation. \r\nAssessment not able to be influenced by knowledge of allocation. \r\n",null,null,"PY","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.","N",null,"N","Absolute number of events were reported. ","Low","Low","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 15.20","GUI2002A2","AW&CC","Guinn 2002",2675243,"Betamethasone","Placebo","Fetal death","\"stillborn\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre was used. The pharmacy then assigned participants to intervention or placebo groups. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat. ","NA",null,"Low","Low","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.\r\n\r\n\r\n\r\nAnalysis was by intention-to-treat. \r\n",null,null,"Y",">95% had data available for this outcome. \r\n\r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low",">95% had data available for this outcome. \r\n\r\n\r\n",null,null,"N","Outcome was objective. ","N",null,"NI","Data on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation. ","N","Assessment not able to be influenced by knowledge of allocation. ","NA","Low","Low","Low","Outcome was objective. \r\n\r\nData on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation. \r\nAssessment not able to be influenced by knowledge of allocation. \r\nLow",null,null,"PY","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.","N",null,"N","Absolute number of events was reported. ","Low","Low","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 15.21","GUI2002A3","AW&CC","Guinn 2002",2675243,"Betamethasone","Placebo","Neonatal death","\"perinatal death\" minus fetal death","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre was used. The pharmacy then assigned participants to intervention or placebo groups. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat. ","NA",null,"Low","Low","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.\r\n\r\n\r\n\r\nAnalysis was by intention-to-treat. \r\n",null,null,"Y",">95% had data available for this outcome. \r\n\r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low",">95% had data available for this outcome. \r\n\r\n\r\n",null,null,"N","Outcome was objective. ","N",null,"NI","Data on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation. ","N","Assessment not able to be influenced by knowledge of allocation. ","NA","Low","Low","Low","Outcome was objective. \r\n\r\nData on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation. \r\nAssessment not able to be influenced by knowledge of allocation. \r\nLow",null,null,"PY","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.","N",null,"N","Absolute number of events was reported. ","Low","Low","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 15.21","GUI2002A5","AW&CC","Guinn 2002",2675243,"Betamethasone","Placebo","Respiratory distress syndrome(RDS) (however defined by authors)","RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre was used. The pharmacy then assigned participants to intervention or placebo groups. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat. ","NA",null,"Low","Low","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.\r\n\r\n\r\n\r\nAnalysis was by intention-to-treat. \r\n",null,null,"Y",">95% had data available for this outcome. \r\n\r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low",">95% had data available for this outcome. \r\n\r\n\r\n",null,null,"N","Based on clinical findings, radiography and oxygen requirement.  ","N",null,"NI","Data on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation. ","N","Assessment not likely to be influenced by knowledge of allocation as outcome predefined and requiring minimal judgement. ","NA","Low","Low","Low","Based on clinical findings, radiography and oxygen requirement.  \r\n\r\nData on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation. \r\nAssessment not likely to be influenced by knowledge of allocation as outcome predefined and requiring minimal judgement. \r\nLow",null,null,"PY","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.","N",null,"N","Absolute number of events were reported. ","Low","Low","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.\r\n",null,null,"Low","Low","Low risk of bias for all domains. \r\n"]
["2022/01/14 15.21","GUI2002A6","AW&CC","Guinn 2002",2675243,"Betamethasone","Placebo","Severe RDS (however defined by authors",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre was used. The pharmacy then assigned participants to intervention or placebo groups. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat. ","NA",null,"Low","Low","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.\r\n\r\n\r\n\r\nAnalysis was by intention-to-treat. \r\n",null,null,"Y",">95% had data available for this outcome. \r\n\r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low",">95% had data available for this outcome. \r\n\r\n\r\n",null,null,"N","Based on RDS diagnosis plus mechanical ventilation and surfactant treatment. ","PN",null,"NI","Data on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation. ","PN","Assessment not likely to be influenced by knowledge of allocation as outcome predefined and requiring minimal judgement. ","NA",null,"Low","Low","Based on RDS diagnosis plus mechanical ventilation and surfactant treatment. \r\n\r\nData on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation. \r\nAssessment not likely to be influenced by knowledge of allocation as outcome predefined and requiring minimal judgement. \r\n",null,null,"PY","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.","N",null,"N","Absolute number of events was reported. ","Low","Low","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 15.21","GUI2002A7","AW&CC","Guinn 2002",2675243,"Betamethasone","Placebo","Severe lung disease (however defined by authors)",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre was used. The pharmacy then assigned participants to intervention or placebo groups. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat. ","NA",null,"Low","Low","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.\r\n\r\n\r\n\r\nAnalysis was by intention-to-treat. \r\n",null,null,"Y",">95% had data available for this outcome. \r\n\r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low",">95% had data available for this outcome. \r\n\r\n\r\n",null,null,"N","Based on RDS diagnosis plus mechanical ventilation and surfactant treatment. ","PN",null,"NI","Data on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation. ","PN","Assessment not likely to be influenced by knowledge of allocation as outcome predefined and requiring minimal judgement. ","NA",null,"Low","Low","Based on RDS diagnosis plus mechanical ventilation and surfactant treatment. \r\n\r\nData on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation. \r\nAssessment not likely to be influenced by knowledge of allocation as outcome predefined and requiring minimal judgement. \r\n",null,null,"PY","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.","N",null,"N","Absolute number of events was reported. ","Low","Low","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 15.21","GUI2002A8","AW&CC","Guinn 2002",2675243,"Betamethasone","Placebo","Chronic lung disease (however defined by authors)",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre was used. The pharmacy then assigned participants to intervention or placebo groups. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat. ","NA",null,"Low","Low","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.\r\n\r\n\r\n\r\nAnalysis was by intention-to-treat. \r\n",null,null,"Y",">95% had data available for this outcome. \r\n\r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low",">95% had data available for this outcome. \r\n\r\n\r\n",null,null,"N",null,"PN",null,"NI","Data on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation. ","PN","Assessment not likely to be influenced by knowledge of allocation as outcome predefined and requiring minimal judgement. ","NA",null,"Low","Low","\r\n\r\nData on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation. \r\nAssessment not likely to be influenced by knowledge of allocation as outcome predefined and requiring minimal judgement. \r\n",null,null,"PY","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.","PN",null,"N","Absolute number of events were reported. ","Low","Low","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 15.21","GUI2002A9","AW&CC","Guinn 2002",2675243,"Betamethasone","Placebo","Severe IVH (grade 3 and 4)",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre was used. The pharmacy then assigned participants to intervention or placebo groups. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat. ","NA",null,"Low","Low","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.\r\n\r\n\r\n\r\nAnalysis was by intention-to-treat. \r\n",null,null,"PN","Only 221 (44%) of the infants had a cranial USS analysis performed. ","N","No sensitivity analysis performed. ","PN","USS were performed if clinically indicated and this is unlikely to vary as healthcare staff were blinded. ","NA",null,"Low","Low","Only 221 (44%) of the infants had a cranial USS analysis performed. \r\nNo sensitivity analysis performed. \r\nUSS were performed if clinically indicated and this is unlikely to vary as healthcare staff were blinded. \r\n",null,null,"N",null,"PN",null,"NI","Data on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation.  ","PN","\r\nOutcome unlikely to be affected by knowledge of allocation as grading criteria were clearly defined and required little subjective judgement.  ","NA",null,"Low","Low","\r\n\r\nData on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation.  Outcome unlikely to be affected by knowledge of allocation as grading criteria were clearly defined and required little subjective judgement.  \r\n",null,null,"PY","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.","PN","Use of grade 3 and 4 to define severe IVH is a standard practice. ","N","Absolute number of events was reported. ","Low","Low","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results. Use of grade 3 and 4 to define severe IVH is a standard practice. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 15.22","GUI2002A10","AW&CC","Guinn 2002",2675243,"Betamethasone","Placebo","Intraventricular haemorrhage (IVH).",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre was used. The pharmacy then assigned participants to intervention or placebo groups. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat. ","NA",null,"Low","Low","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.\r\n\r\n\r\n\r\nAnalysis was by intention-to-treat. \r\n",null,null,"PN","Only 221 of the infants had a cranial USS analysis performed. ","N","No sensitivity analysis performed. ","PN","USS were performed if clinically indicated and this is unlikely to vary due to blinding of healthcare staff. ","NA",null,"Low","Low","Only 221/502(44%) of the infants had a cranial USS analysis performed. \r\nNo sensitivity analysis performed.  USS were performed if clinically indicated and this is unlikely to vary due to blinding of healthcare staff. \r\n",null,null,"N",null,"PN",null,"NI","Data on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation.  ","PN","Outcome unlikely to be affected by knowledge of allocation as grading criteria were clearly defined based on imaging or autopsy findings and required little subjective judgement.  ","NA",null,"Low","Low","\r\n\r\nData on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation.  \r\nOutcome unlikely to be affected by knowledge of allocation as grading criteria were clearly defined based on imaging or autopsy findings and required little subjective judgement.  \r\n",null,null,"PY","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.","PN",null,"N","Absolute number of events was reported. ","Low","Low","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 15.22","GUI2002A11","AW&CC","Guinn 2002",2675243,"Betamethasone","Placebo","Necrotising enterocolitis (however defined by authors)",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre was used. The pharmacy then assigned participants to intervention or placebo groups. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat. ","NA",null,"Low","Low","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.\r\n\r\n\r\n\r\nAnalysis was by intention-to-treat. \r\n",null,null,"Y",">95% had data available for this outcome. \r\n\r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low",">95% had data available for this outcome. \r\n\r\n\r\n",null,null,"N","based on clinical, radiological, surgical and autopsy findings.","PN",null,"NI","Data on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation. ","PN","Assessment not likely to be influenced by knowledge of allocation as outcome predefined and requiring minimal judgement. ","NA",null,"Low","Low","Data on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation. \r\nAssessment not likely to be influenced by knowledge of allocation as outcome was predefined (based on clinical, radiological, surgical and autopsy findings) and required minimal judgement. ",null,null,"PY","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.","PN",null,"N","Absolute number of events was reported. ","Low","Low","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 15.22","GUI2002A12","AW&CC","Guinn 2002",2675243,"Betamethasone","Placebo","Composite serious outcome (however defined by authors)",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre was used. The pharmacy then assigned participants to intervention or placebo groups. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat. ","NA",null,"Low","Low","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.\r\n\r\n\r\n\r\nAnalysis was by intention-to-treat. \r\n",null,null,"Y",">95% had data available for this outcome but components requiring USS assessment were only assessed in 221 participants as clinically indicated.  \r\n\r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low",">95% had data available for this outcome but components requiring USS assessment were only assessed in 221 participants as clinically indicated.  \r\n\r\n\r\n\r\n\r\n\r\n",null,null,"N",null,"PN",null,"NI","Data on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation. ","PN","Components of the composite were all well defined and required minimal individual judgment by assessors. ","NA",null,"Low","Low","\r\n\r\nData on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation. \r\nComponents of the composite were all well defined and required minimal individual judgment by assessors. \r\n",null,null,"PY","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.","PN","Composite was clearly defined in methods and interim analysis. ","N","Absolute number of events was reported. ","Low","Low","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results. Composite clearly defined in methods. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 15.23","GUI2002F1","AW&CC","Guinn 2002",2675243,"Betamethasone","Placebo","gestational age at birth","very preterm birth and mean gestational age at birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre was used. The pharmacy then assigned participants to intervention or placebo groups. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat. ","NA",null,"Low","Low","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.\r\n\r\n\r\n\r\nAnalysis was by intention-to-treat. \r\n",null,null,"Y",">95% had data available for this outcome. \r\n\r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low",">95% had data available for this outcome. \r\n\r\n\r\n",null,null,"N",null,"N",null,"NI","Data on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation. ","N","Assessment of gestational age was by last menstrual period and confirmed by ultrasound assessment.  ","NA",null,"Low","Low","\r\n\r\nData on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation. \r\nAssessment of gestational age was by last menstrual period and confirmed by ultrasound assessment.  \r\n",null,null,"PY","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.","N",null,"N","Absolute numbers in each category were reported.  ","Low","Low","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 15.23","GUI2002F4","AW&CC","Guinn 2002",2675243,"Betamethasone","Placebo","Proven neonatal infection while in the NICU","\"Proven sepsis\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre was used. The pharmacy then assigned participants to intervention or placebo groups. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat. ","NA",null,"Low","Low","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.\r\n\r\n\r\n\r\nAnalysis was by intention-to-treat. \r\n",null,null,"Y",">95% had data available for this outcome. \r\n\r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low",">95% had data available for this outcome. \r\n\r\n\r\n",null,null,"PN","Presence of clinical findings, positive blood cultures and required antibiotics.","PN",null,"NI","Data on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation. ","PN","Assessment not likely to be influenced by knowledge of allocation as outcome predefined and requiring minimal judgement. ","NA",null,"Low","Low","Presence of clinical findings, positive blood cultures and required antibiotics.\r\n\r\nData on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation. \r\nAssessment not likely to be influenced by knowledge of allocation as outcome predefined and requiring minimal judgement. \r\n",null,null,"PY","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.","PN",null,"PN","Absolute number of events was reported. ","Low","Low","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 15.23","GUI2002F8","AW&CC","Guinn 2002",2675243,"Betamethasone","Placebo","Periventricular leukomalacia (however defined by authors)","\"isolated PVL\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre was used. The pharmacy then assigned participants to intervention or placebo groups. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat. ","NA",null,"Low","Low","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.\r\n\r\n\r\n\r\nAnalysis was by intention-to-treat. \r\n",null,null,"PN","Only 221 of the infants had a cranial USS analysis performed. ","N","No sensitivity analysis performed. ","PN","USS were performed if clinically indicated and this is unlikely to vary due to blinding of healthcare staff. ","NA",null,"Low","Low","Only 221 of the infants had a cranial USS analysis performed. \r\nNo sensitivity analysis performed. \r\nUSS were performed if clinically indicated and this is unlikely to vary due to blinding of healthcare staff. \r\n",null,null,"N","By cranial ultrasonography.","PN",null,"NI","Data on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation. ","PN","Outcome unlikely to be affected by knowledge of allocation as the outcome was clearly defined and required little subjective judgement.  ","NA",null,"Low","Low","By cranial ultrasonography.\r\n\r\nData on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation. \r\nOutcome unlikely to be affected by knowledge of allocation as the outcome was clearly defined and required little subjective judgement.  \r\n",null,null,"PY","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.","PN",null,"N","Absolute number of events was reported. ","Low","Low","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 15.23","GUI2002F15","AW&CC","Guinn 2002",2675243,"Betamethasone","Placebo","Use of surfactant","\"received one or more course of surfactant\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre was used. The pharmacy then assigned participants to intervention or placebo groups. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat. ","NA",null,"Low","Low","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.\r\n\r\n\r\n\r\nAnalysis was by intention-to-treat. \r\n",null,null,"Y",">95% had data available for this outcome. \r\n\r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low",">95% had data available for this outcome. \r\n\r\n\r\n",null,null,"N","Outcome based on treatment provided by clinical team who were blinded to allocation. ","PN",null,"NI","Data on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation.  ","PN","Outcome unlikely to be affected by knowledge of allocation. ","NA",null,"Low","Low","Outcome based on treatment provided by clinical team who were blinded to allocation. \r\n\r\nData on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation.  \r\nOutcome unlikely to be affected by knowledge of allocation. \r\n",null,null,"PY","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.","PN",null,"N","Absolute number of events was reported. ","Low","Low","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 15.23","GUI2002F17","AW&CC","Guinn 2002",2675243,"Betamethasone","Placebo","Use of postnatal corticosteroids","\"postnatal steroids for BPD\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre was used. The pharmacy then assigned participants to intervention or placebo groups. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat. ","NA",null,"Low","Low","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.\r\n\r\n\r\n\r\nAnalysis was by intention-to-treat. \r\n",null,null,"Y",">95% had data available for this outcome. \r\n\r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low",">95% had data available for this outcome. \r\n\r\n\r\n",null,null,"N","Outcome based on treatment provided by clinical team who were blinded to allocation. ","N",null,"NI","Data on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation.  \r\n","PN","Outcome assessment unlikely to be affected by knowledge of allocation. ","NA",null,"Low","Low","Outcome based on treatment provided by clinical team who were blinded to allocation. \r\n\r\nData on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation.  \r\n\r\nOutcome assessment unlikely to be affected by knowledge of allocation. \r\n",null,null,"PY","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.","PN",null,"N","Absolute number of events was reported. ","Low","Low","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 15.36","GUI2002L1","AW&CC","Guinn 2002",2675243,"Betamethasone","Placebo","Birthweight","Birthweight","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre was used. The pharmacy then assigned participants to intervention or placebo groups. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat. ","NA",null,"Low","Low","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.\r\n\r\n\r\n\r\nAnalysis was by intention-to-treat. \r\n",null,null,"Y",">95% had data available for this outcome. \r\n\r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low",">95% had data available for this outcome. \r\n\r\n\r\n",null,null,"N",null,"N",null,"NI","Data on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation.  \r\n","PN","Outcome assessment unable to be affected by knowledge of allocation. ","NA",null,"Low","Low","\r\n\r\nData on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation.  \r\n\r\nOutcome assessment unable to be affected by knowledge of allocation. \r\n",null,null,"PY","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.","PN",null,"N",null,"Low","Low","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. \r\n"]
["2022/01/14 15.23","GUI2002L2","AW&CC","Guinn 2002",2675243,"Betamethasone","Placebo","Interval between trial entry and birth","\"latency interval\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre was used. The pharmacy then assigned participants to intervention or placebo groups. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat. ","NA",null,"Low","Low","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.\r\n\r\n\r\n\r\nAnalysis was by intention-to-treat. \r\n",null,null,"Y",">95% had data available for this outcome. \r\n\r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low",">95% had data available for this outcome. \r\n\r\n\r\n",null,null,"N",null,"N",null,"NI","Data on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation.  ","N","Outcome assessment unable to be affected by knowledge of allocation. ","NA",null,"Low","Low","Data on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation.  \r\n\r\nOutcome assessment unable to be affected by knowledge of allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.","N",null,"N",null,"Low","Low","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. \r\n\r\n"]
["2022/01/14 15.23","GUI2002L3","AW&CC","Guinn 2002",2675243,"Betamethasone","Placebo","Head circumference at birth","\"head circumference\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre was used. The pharmacy then assigned participants to intervention or placebo groups. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat. ","NA",null,"Low","Low","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.\r\n\r\n\r\n\r\nAnalysis was by intention-to-treat. \r\n",null,null,"Y",">95% had data available for this outcome. \r\n\r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low",">95% had data available for this outcome. \r\n\r\n\r\n",null,null,"N",null,"N",null,"NI","Data on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation.  ","PN","Outcome unlikely to be affected by knowledge of allocation. ","NA",null,"Low","Low","\r\n\r\nData on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation.  \r\nOutcome unlikely to be affected by knowledge of allocation. \r\n",null,null,"PY","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.","PN",null,"N",null,"Low","Low","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 15.23","GUI2002Q4","AW&CC","Guinn 2002",2675243,"Betamethasone","Placebo","Length of infant hospitalisation ","\"neonatal hospital stay\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre was used. The pharmacy then assigned participants to intervention or placebo groups. ","N","No marked imbalance of baseline characteristics. ","Low","Low","Computer-generated randomisation logs prepared centrally and distributed to the research pharmacist at each clinical site. Stratification by centre. No marked imbalance of baseline characteristics. \r\n",null,null,"N","N","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.","NA",null,"NA",null,"NA",null,"Y","Analysis was by intention-to-treat. ","NA",null,"Low","Low","The placebo syringes were indistinguishable from the syringes containing betamethasone. Patients and healthcare workers were blinded to study group.\r\n\r\n\r\n\r\nAnalysis was by intention-to-treat. \r\n",null,null,"Y",">95% had data available for this outcome. \r\n\r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low",">95% had data available for this outcome. \r\n\r\n\r\n",null,null,"N",null,"N",null,"NI","Data on outcomes collected prospectively from clinical records. Healthcare workers were blinded to treatment allocation. ","PN","Outcome unable to be affected by knowledge of allocation. ","NA",null,"Low","Low","\r\n\r\nData on outcomes collected prospectively from clinical records. It was not stated if assessors were blinded to allocation.  \r\nOutcome unable to be affected by knowledge of allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.","N",null,"N",null,"Low","Low","SAP and protocol were not available to review. No registration document identified. Precoded forms were used to enter predefined outcomes.  Outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. \r\n"]
["2022/01/15 11.30","PEL2007A1","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","Fetal or neonatal or infant death","\"fetus mortus\" + death during hospitalisation","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data reported for this outcome.\r\n\r\n\r\n",null,null,"N",null,"PN","Outcome was objective. ","N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","\r\nOutcome was objective. \r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results.","N",null,"N",null,"Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 11.30","PEL2007A2","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","Fetal death","\"fetus mortus\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data reported for this outcome.\r\n\r\n\r\n",null,null,"N",null,"PN","Outcome was objective. ","N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","\r\nOutcome was objective. \r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results.","N",null,"N",null,"Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 11.30","PEL2007A3","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","Neonatal death","Death during first hospitalisation","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data reported for this outcome.\r\n\r\n\r\n",null,null,"N",null,"PN","Outcome was objective. ","N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","\r\nOutcome was objective. \r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results.","N",null,"N",null,"Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 11.30","PEL2007A5","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","RDS","RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data reported for this outcome.\r\n\r\n\r\n",null,null,"N","Diagnosis was based on clinical and radiological criteria, including need for oxygen or surfactant therapy. ","PN",null,"N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Diagnosis was based on clinical and radiological criteria, including need for oxygen or surfactant therapy. \r\n\r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results.","N","Outcome clearly defined with timeframe. ","N","Absolute numbers of events were reported with analysis as per methods. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 11.31","PEL2007A6","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","Severe RDS (however defined by authors","Severe RDS (however defined by authors","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data reported for this outcome.\r\n\r\n\r\n",null,null,"N","Outcome based on RDS diagnosis along with ventilation requirement for >24hours despite surfactant therapy. ","PN",null,"N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Outcome based on RDS diagnosis along with ventilation requirement for >24hours despite surfactant therapy. \r\n\r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results.","N","Outcome clearly defined with timeframe. ","N","Absolute numbers of events were reported with analysis as per methods. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results.\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 11.31","PEL2007A7","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","Severe lung disease","Severe RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data reported for this outcome.",null,null,"N","Outcome based on RDS diagnosis along with ventilation requirement for >24hours despite surfactant therapy. ","PN",null,"N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Outcome based on RDS diagnosis along with ventilation requirement for >24hours despite surfactant therapy. \r\n\r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results.","N","Outcome clearly defined with timeframe. ","N","Absolute numbers of events were reported with analysis as per methods. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results.\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 11.31","PEL2007A8","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","Chronic lung disease","BPD","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data reported for this outcome.\r\n\r\n",null,null,"N","Outcome based on diagnosis of bronchopulmonary dysplasia(need for supplemental oxygen or ventilation at 36 weeks post menstrual age or 4 weeks post natal). ","PN",null,"N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Outcome based on diagnosis of bronchopulmonary dysplasia(need for supplemental oxygen or ventilation at 36 weeks post menstrual age or 4 weeks post natal age). \r\n\r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results.","N","Outcome clearly defined, including timeframe. ","PN","Absolute numbers of events were reported with analysis as per methods. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 11.31","PEL2007A9","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","severe IVH","IVH grade 3 or 4 ","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"PN"," \"few infants\" were not examined as transferred to a central hospital or were born at term and \"appeared healthy\". ","N",null,"PY","Transferred infants may have been more unwell and more likely to have the outcome of interest. ","PN",null,"Some concerns","Some concerns"," \"few infants\" were not examined as transferred to a central hospital or were born at term and \"appeared healthy\". \r\n\r\nTransferred infants may have been more unwell and more likely to have the outcome of interest. \r\n",null,null,"N",null,"PN","Cranial USS was performed routinely but \"few infants\" were not examined as transferred to a central hospital.","N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","\r\nCranial USS was performed routinely but \"few infants\" were not examined as transferred to a central hospital.\r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results.","PN","IVH grading clearly defined. Outcome clearly defined including timescale. ","N","Absolute numbers of events were reported with analysis as per methods. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results.\r\nIVH grading clearly defined. ",null,null,"Some concerns","Some concerns"," Some concerns for missing outcome data as the infants transferred to a central hospital may have been more unwell and at higher risk of the outcome. \r\n"]
["2022/01/15 11.31","PEL2007A10","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","IVH","IVH, any grade","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"PN"," \"few infants\" were not examined as transferred to a central hospital or were born at term and \"appeared healthy\". ","N",null,"PY","Transferred infants may have been more unwell and more likely to have the outcome of interest. ","PN",null,"Some concerns","Some concerns"," \"few infants\" were not examined as transferred to a central hospital or were born at term and \"appeared healthy\". \r\n\r\nTransferred infants may have been more unwell and more likely to have the outcome of interest. \r\n",null,null,"N",null,"PN","Cranial USS was performed routinely but \"few infants\" were not examined as transferred to a central hospital or \"appeared healthy\".","N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","\r\nCranial USS was performed routinely but \"few infants\" were not examined as transferred to a central hospital or \"appeared healthy\".\r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results.","PN","Outcome clearly defined including timescale. ","N","Absolute numbers of events were reported with analysis as per methods. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. IVH grading clearly defined\r\n",null,null,"Some concerns","Some concerns"," Some concerns of missing outcome data as the infants transferred to a central hospital may have been more unwell and at higher risk of the outcome. "]
["2022/01/15 11.31","PEL2007A11","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","NEC","NEC","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data for this outcome reported.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome reported.\r\n\r\n\r\n",null,null,"N","Necrotizing enterocolitis was diagnosed based on clearly defined staging criteria. ","PN",null,"N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Necrotizing enterocolitis was diagnosed based on clearly defined staging criteria. \r\n\r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results.","PN","Outcome clearly defined including timescale. ","PN","Absolute numbers of events were reported with analysis as per methods. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results.\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 11.31","PEL2007A12","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","composite serious outcome","death or RDS or severe IVH","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data for this outcome reported but for IVH outcome a \"few infants\" were not examined for IVH as they had transferred to a central hospital. ","NA",null,"NA",null,"NA",null,"Low","Low","A\"few infants\" were not examined for IVH as they had transferred to a central hospital or were healthy appearing term infants. \r\n\r\n\r\n",null,null,"N","The composite outcome was defined based on occurrence of death, RDS or severe IVH. ","PN",null,"N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","The composite outcome was defined based on occurrence of death, RDS or severe IVH. \r\n\r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. Composite outcome clearly defined in methods and registration document. ","PN","Outcome clearly defined including timescale. ","PN","Absolute numbers of events were reported with analysis as per methods. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. Composite outcome clearly defined in methods and registration document. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 13.00","PEL2007F1","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","Gestational age at birth","mean GA at birth, extremely preterm birth <28weeks, very preterm birth <34 weeks. ","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data reported for this outcome.\r\n\r\n\r\n",null,null,"N","Gestational age was measured by last menstrual period and confirmed with ultrasound at <20 weeks gestation.","N",null,"N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Gestational age was measured by last menstrual period and confirmed with ultrasound at <20 weeks gestation.\r\n\r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results.","N",null,"PN",null,"Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 13.06","PEL2007F2","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","SGA","SGA","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data reported for this outcome.",null,null,"N","Weight assessment not stated but unlikely to differ between groups. ","N",null,"N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Weight assessment not stated but unlikely to differ between groups. \r\n\r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","PN","The definition used was a standard definition of SGA. ","N","Absolute numbers of events were reported with analysis as per methods. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. \r\nThe definition used was a standard definition of SGA. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 13.07","PEL2007F4","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","infection whilst in NICU","early + late systemic infection","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data reported for this outcome.\r\n\r\n",null,null,"N",null,"PN",null,"N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Outcome definition not stated but ascertainment unlikely to have differed, given blinding of treating team and investigators.\r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","N","Outcome clearly defined including timescale. ","N","Absolute numbers of events were reported with analysis as per methods. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. \r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 13.07","PEL2007F5","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","Early systemic neonatal infection","Sepsis age <3days","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data reported for this outcome. \r\n\r\n\r\n",null,null,"N",null,"PN",null,"N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","\r\n\r\nOutcome definition not stated but ascertainment unlikely to have differed, given blinding of treating team and investigators.\r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","N","Outcome clearly defined in registration document. ","N","Absolute numbers of events were reported with analysis as per methods. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. \r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 13.08","PEL2007F6","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","Late systemic neonatal infection","Sepsis ≥ 3 days after birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data reported for this outcome.\r\n\r\n\r\n",null,null,"N",null,"PN",null,"N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","\r\n\r\nOutcome definition not stated but ascertainment unlikely to have differed, given blinding of treating team and investigators.\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","N","Outcome clearly defined in registration document. ","N","Absolute numbers of events were reported with analysis as per methods. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 13.09","PEL2007F7","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","ROP","ROP, any grade","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data reported for this outcome. \r\n\r\n\r\n",null,null,"PN","Method of assessment of ROP not stated but unlikely to have differed between groups, given blinding of the treating team. ","PN",null,"N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Method of assessment of ROP not stated but unlikely to have differed between groups, given blinding of the treating team. \r\n\r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","N","Outcome clearly defined including timescale (32 weeks PMA or 4-7weeks after birth). ","N","Absolute numbers of events were reported with analysis as per methods. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. \r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 13.09","PEL2007F8","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","PVL","cystic periventricular leukomalacia","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"PN"," \"few infants\" were not examined as transferred to a central hospital or were born at term and \"appeared healthy\". ","N",null,"PY","Transferred infants may have been more unwell and more likely to have the outcome of interest. ","PN",null,"Some concerns","Some concerns"," \"few infants\" were not examined as transferred to a central hospital or were born at term and \"appeared healthy\". \r\n\r\nTransferred infants may have been more unwell and more likely to have the outcome of interest. \r\n",null,null,"N",null,"N","Cranial USS was performed routinely but \"few infants\" were not examined as transferred to a central hospital or \"appeared healthy\".","N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","\r\nCranial USS was performed routinely but \"few infants\" were not examined as transferred to a central hospital or \"appeared healthy\".\r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","PN","Outcome clearly defined including timescale. ","N","Absolute numbers of events were reported with analysis as per methods. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. \r\n",null,null,"Some concerns","Some concerns"," Some concerns of missing outcome data as the infants transferred to a central hospital may have been more unwell and at higher risk of the outcome. Given the total number with this outcome was low, this could affect the overall assessment. "]
["2022/01/15 13.09","PEL2007F10","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","PDA","PDA","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data reported for this outcome. \r\n\r\n\r\n",null,null,"PN","PDA defined by requirement for prostaglandin or surgical closure.  ","PN",null,"N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","PDA defined by requirement for prostaglandin or surgical closure.  \r\n\r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","PN","Outcome clearly defined including timescale. ","N","Absolute numbers of events were reported with analysis as per methods. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 13.11","PEL2007F12","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","Use of invasive respiratory support ","mechanical ventilation","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome. ","NA",null,"NA",null,"NA","Low","Low","Low","No missing data reported for this outcome. ",null,null,"N","Outcome based on care administered by the treating team, who were blinded to allocation. ","PN",null,"N","Study investigators were blinded to allocation. ","NA",null,"NA","Low","Low","Low","Outcome based on care administered by the treating team, who were blinded to allocation. \r\n\r\nStudy investigators were blinded to allocation. ",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","PN",null,"N","Absolute numbers of events were reported with analysis as per methods. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 13.11","PEL2007F13","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","Use of non-invasive respiratory support ","nasal CPAP","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome.","NA",null,"NA",null,"NA","Low","Low","Low","No missing data reported for this outcome.",null,null,"N","Outcome based on care administered by the treating team, who were blinded to allocation. ","PN",null,"N","Study investigators were blinded to allocation. ","NA",null,"NA","Low","Low","Low","Outcome based on care administered by the treating team, who were blinded to allocation. \r\n\r\nStudy investigators were blinded to allocation. \r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","PN",null,"N","Absolute numbers of events were reported with analysis as per methods. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 13.13","PEL2007F15","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","Use of surfactant","Use of surfactant","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data reported for this outcome.\r\n\r\n\r\n",null,null,"N","Outcome based on care administered by the treating team, who were blinded to allocation. ","PN",null,"N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Outcome based on care administered by the treating team, who were blinded to allocation. \r\n\r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","PN",null,"N","Absolute numbers of events were reported with analysis as per methods. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 13.16","PEL2007F20","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","Use of inotropic support","\"inotropes\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data reported for this outcome.\r\n\r\n",null,null,"N","Outcome based on care administered by the treating team, who were blinded to allocation. ","PN",null,"N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Outcome based on care administered by the treating team, who were blinded to allocation. \r\n\r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was not in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","PN","Outcome clearly defined including timescale. ","N","Absolute numbers of events were reported with analysis as per methods. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was not in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. \r\nOutcome clearly defined including timescale. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 13.16","PEL2007L1","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","Birthweight","Birthweight","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data reported for this outcome.",null,null,"N","Outcome measurement method not stated but was unlikely to have differed between groups. ","N",null,"N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Outcome measurement method not stated but was unlikely to have differed between groups. \r\n\r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","N",null,"N","Mean and SD were the only eligible analysis reported. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 13.18","PEL2007L2","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","Interval between trial entry and birth","Time from intervention to birth, mean and SD calculated from median and IQR","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data reported for this outcome.\r\n\r\n\r\n",null,null,"N","Outcome used was objective. ","PN",null,"N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Outcome used was objective. \r\n\r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was not in the trial registration but outcome definition and analysis unlikely to have been selected based on results. ","N",null,"N","Median and IQR were used to calculate mean and SD estimates to be eligible for inclusion.","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was not in the trial registration but outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 13.16","PEL2007L3","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","Head circumference at birth","HC","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data reported for this outcome.\r\n\r\n\r\n",null,null,"N","Outcome measurement method not stated but was unlikely to have differed between groups. ","N",null,"N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Outcome measurement method not stated but was unlikely to have differed between groups. \r\n\r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","N",null,"N","Mean and SD were the only eligible analysis reported. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 13.17","PEL2007L4","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","Length at birth ","Length","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low","No missing data reported for this outcome. \r\n\r\n\r\n",null,null,"N","Outcome measurement method not stated but was unlikely to have differed between groups. ","N",null,"N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Outcome measurement method not stated but was unlikely to have differed between groups. \r\n\r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","N",null,"N","Mean and SD were the only eligible analysis reported. ","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 13.19","PEL2007L8","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","Duration of invasive respiratory support ","Duration of mechanical ventilation, mean and SD calculated from median and IQR","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data reported for this outcome.",null,null,"N","Outcome based on care administered by the treating team, who were blinded to allocation. ","PN",null,"N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Outcome based on care administered by the treating team, who were blinded to allocation. \r\n\r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","N",null,"N","Median and IQR were used to calculate mean and SD estimates to be eligible for inclusion.","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 13.19","PEL2007L9","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","Duration of non-invasive respiratory support ","Duration of nasal CPAP, calculated mean and SD from Median and IQR","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data reported for this outcome.",null,null,"N","Outcome based on care administered by the treating team, who were blinded to allocation. ","PN",null,"N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Outcome based on care administered by the treating team, who were blinded to allocation. \r\n\r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","N",null,"N","Median and IQR were used to calculate mean and SD estimates to be eligible for inclusion.","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. \r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 13.20","PEL2007L10","AW&JH","Peltoniemi2007",2675274,"Betamethasone","Placebo","Duration of oxygen supplementation","Calculated mean and SD from median and IQR","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","PY","Y","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.","N","Randomisation was stratified by centre for gestational age and multiple gestations. No marked imbalance of baseline characteristics. ","Low","Low","Randomisation performed centrally using opaque, sealed envelopes opened after informed consent was obtained. Nurses, doctors and participants were blinded to allocation. Method of random sequence generation was not stated.\r\nRandomisation was stratified by centre for gestational age and multiple gestations. \r\nNo marked imbalance of baseline characteristics. ",null,null,"N","PN","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis. ","NA",null,"Low","Low","Clinical staff, participants and study investigators were blinded to allocation. Study intervention and placebo were prepared in identical, masked syringes. \r\n\r\n\r\n\r\nIntention to treat analysis. \r\n",null,null,"Y","No missing data reported for this outcome.","NA",null,"NA",null,"NA",null,"Low","Low","No missing data reported for this outcome.",null,null,"N","Outcome based on care administered by the treating team, who were blinded to allocation. ","PN",null,"N","Study investigators were blinded to allocation. ","NA",null,"NA",null,"Low","Low","Outcome based on care administered by the treating team, who were blinded to allocation. \r\n\r\nStudy investigators were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ","N",null,"N","Median and IQR were used to calculate mean and SD estimates to be eligible for inclusion.","Low","Low","SAP and protocol were not available for review but analysis plans were included on the registered trial protocol. Outcome was in the trial registration. Outcome definition and analysis unlikely to have been selected based on results. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 08.58","WAP2006A1","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","fetal or neonatal or infant death","fetal or neonatal death","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient.\r\nNo marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"N","For multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. ","PN",null,"PY",null,"PN",null,"Some concerns","Some concerns","For multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. \r\n\r\n\r\n",null,null,"N",null,"PN",null,"N","Deidentified charts underwent blinded central review by 2 neonatologists. ","NA",null,"NA",null,"Low","Low","\r\n\r\nDeidentified charts underwent blinded central review by 2 neonatologists. \r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ","PN","Outcome and timeframe clearly defined in methods. ","N","Absolute number of outcomes was eligible for inclusion. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ",null,null,"Some concerns","Some concerns","Some concerns as for multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. "]
["2022/01/15 08.58","WAP2006A5","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","RDS","RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient.\r\nNo marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"N","For multiple pregnancies an event was reported if either or both infants had the outcome. ","PN",null,"PY",null,"PN","Some concerns","Some concerns","Some concerns","For multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. \r\n\r\n",null,null,"N","Outcome based on clinical findings and radiographic findings","PN",null,"N","Deidentified charts underwent blinded central review by 2 neonatologists. ","NA",null,"NA",null,"Low","Low","Outcome based on clinical findings and radiographic findings\r\n\r\nDeidentified charts underwent blinded central review by 2 neonatologists. \r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ","PN","Outcome and timeframe clearly defined in methods. ","N","Absolute number of outcomes was eligible for inclusion. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ",null,null,"Some concerns","Some concerns","Some concerns as for multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. "]
["2022/01/15 08.58","WAP2006A6","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","Severe RDS (however defined by authors","Severe RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient.\r\nNo marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"N","An outcome was reported for multiple pregnancies if either or both infants had the outcome, with the more severe determining the overall severity assessment.  ","PN",null,"PY",null,"PN",null,"Some concerns","Some concerns","An event was reported for multiple pregnancies if either or both infants had the outcome, with the more severe determining the overall severity assessment. This potentially biases the event incidence and treatment effect estimate. \r\n ",null,null,"N","Outcome based on clinical findings, radiographic findings and treatment with surfactant/oxygen therapy.","PN",null,"N","Deidentified charts underwent blinded central review by 2 neonatologists. ","NA",null,"NA",null,"Low","Low","Outcome based on clinical findings, radiographic findings and treatment with surfactant/oxygen therapy.\r\n\r\nDeidentified charts underwent blinded central review by 2 neonatologists. \r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ","PN","Outcome and timeframe clearly defined in methods. ","N","Absolute number of outcomes was eligible for inclusion. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ",null,null,"Some concerns","Some concerns","Some concerns as multiple pregnancies reported an event if either or both infants had the outcome, with the more severe determining the overall assessment.  This potentially biases the event incidence and treatment effect estimate. \r\n"]
["2022/01/15 08.58","WAP2006A7","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","Severe lung disease","severe RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient.\r\nNo marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"N","An outcome was reported for multiple pregnancies if either or both infants had the outcome, with the more severe determining the overall severity assessment.  ","PN",null,"PY",null,"PN",null,"Some concerns","Some concerns","An outcome was reported for multiple pregnancies if either or both infants had the outcome, with the more severe determining the overall severity assessment.  This potentially biases the event incidence and treatment effect estimate. \r\n",null,null,"N","Outcome based on clinical findings, radiographic findings and treatment with surfactant/oxygen therapy.","PN",null,"N","Deidentified charts underwent blinded central review by 2 neonatologists. ","NA",null,"NA",null,"Low","Low","Outcome based on clinical findings, radiographic findings and treatment with surfactant/oxygen therapy.\r\n\r\nDeidentified charts underwent blinded central review by 2 neonatologists. \r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ","PN","Outcome and timeframe clearly defined in methods. ","N","Absolute number of outcomes was eligible for inclusion. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. \r\n",null,null,"Some concerns","Some concerns","Some concerns as multiple pregnancies reported an event if either or both infants had the outcome, with the more severe determining the overall assessment.  This potentially biases the event incidence and treatment effect estimate. \r\n"]
["2022/01/15 08.58","WAP2006A8","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","Chronic lung disease","chronic lung disease","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient.\r\nNo marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"N","For multiple pregnancies an event was reported if either or both infants had the outcome. ","PN",null,"PY",null,"PN","Some concerns","Some concerns","Some concerns","For multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. \r\n\r\n",null,null,"N","Outcome based on oxygen use at 36 weeks post menstrual age.","PN",null,"N","Deidentified charts underwent blinded central review by 2 neonatologists. ","NA",null,"NA",null,"Low","Low","Outcome based on oxygen use at 36 weeks post menstrual age.\r\n\r\nDeidentified charts underwent blinded central review by 2 neonatologists. \r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ","PN","Outcome and timeframe clearly defined in methods. ","N","Absolute number of outcomes was eligible for inclusion. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. \r\n",null,null,"Some concerns","Some concerns","Some concerns as for multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. "]
["2022/01/15 08.58","WAP2006A10","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","IVH","IVH","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient.\r\nNo marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"N","93%(460/492) had data for this outcome. For multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. ","PN",null,"PY",null,"PN","Some concerns","Some concerns","Some concerns","93%(460/492) had data for this outcome. For multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. ",null,null,"N",null,"PN",null,"N","Head ultrasounds were read centrally by a panel of blinded radiologists. ","NA",null,"NA",null,"Low","Low","\r\n\r\nHead ultrasounds were read centrally by a panel of blinded radiologists. \r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ","PN",null,"N","Absolute number of outcomes was eligible for inclusion. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ",null,null,"Some concerns","Some concerns","Some concerns as for multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. "]
["2022/01/15 08.58","WAP2006A11","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","NEC","NEC","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient.\r\nNo marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"N","For multiple pregnancies an event was reported if either or both infants had the outcome. ","PN",null,"PY",null,"PN","Some concerns","Some concerns","Some concerns","For multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. \r\n\r\n",null,null,"N","Outcome determined from case records. ","PN",null,"N","Deidentified charts underwent blinded central review by 2 neonatologists. ","NA",null,"NA",null,"Low","Low","Outcome determined from case records. \r\n\r\nDeidentified charts underwent blinded central review by 2 neonatologists. \r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ","PN",null,"N","Absolute number of outcomes was eligible for inclusion. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. \r\n",null,null,"Some concerns","Some concerns","Some concerns as for multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. "]
["2022/01/15 08.58","WAP2006A12","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","composite serious outcome","composite neonatal  morbidity","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient.\r\nNo marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"N","An outcome was reported for multiple pregnancies if either or both infants had the outcome, with the more severe determining the overall severity assessment.  ","PN",null,"PY",null,"PN",null,"Some concerns","Some concerns","An outcome was reported for multiple pregnancies if either or both infants had the outcome, with the more severe determining the overall severity assessment.  This potentially biases the event incidence and treatment effect estimate. \r\n",null,null,"N","Clearly defined composite including  neonatal mortality/stillbirth, severe RDS, chronic lung disease, grade III/IV IVH, PVL","PN",null,"N","Deidentified charts underwent blinded central review by 2 neonatologists. ","NA",null,"NA",null,"Low","Low","Clearly defined composite including  neonatal mortality/stillbirth, severe RDS, chronic lung disease, grade III/IV IVH, PVL\r\n\r\nDeidentified charts underwent blinded central review by 2 neonatologists. \r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ","PN","Outcome and timeframe clearly defined in methods. ","N","Absolute number of outcomes was eligible for inclusion. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ",null,null,"Some concerns","Some concerns","Some concerns as multiple pregnancies reported an event if either or both infants had the outcome, with the more severe determining the overall assessment.  This potentially biases the event incidence and treatment effect estimate. \r\n"]
["2022/01/15 08.58","WAP2006F1","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","gestational age at birth ","term birth, preterm birth, mean GA at birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient.\r\nNo marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"Y",">99% had data for this outcome. \r\n","NA",null,"NA",null,"NA",null,"Low","Low",">99% had data for this outcome. \r\n\r\n\r\n\r\n",null,null,"N",null,"N",null,"N","Deidentified charts underwent blinded central review by 2 neonatologists. ","NA",null,"NA",null,"Low","Low","\r\n\r\nDeidentified charts underwent blinded central review by 2 neonatologists. \r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ","N","Outcome and timeframe clearly defined in methods. ","N","Mean and SD or absolute number of events were reported and eligible for inclusion. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/15 08.48","WAP2006F2","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","SGA","BW <10th centile","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient.\r\nNo marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"N","For multiple pregnancies an event was reported if either or both infants had the outcome. ","PN",null,"PY",null,"PN",null,"Some concerns","Some concerns","For multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. \r\n\r\n",null,null,"N",null,"N",null,"N","Deidentified charts underwent blinded central review by 2 neonatologists. ","NA",null,"NA",null,"Low","Low","\r\n\r\nDeidentified charts underwent blinded central review by 2 neonatologists. \r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Birthweight was an outcome in protocol documentation but not SGA.  Both BW <10th and <5th centile were reported but only 10th centile was eligible for this review. ","PN","Measurement was described clearly in methods. Eligibility determined use of <10th centile. ","N","Absolute number of outcomes was eligible for inclusion. ","Low","Low","Protocol with planned statistical analysis was available for review. Birthweight was an outcome in protocol documentation but not SGA.  Both BW <10th and <5th centile were reported but only 10th centile was eligible for this review. . ",null,null,"Some concerns","Some concerns","Some concerns as for multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. "]
["2022/01/15 08.49","WAP2006F4","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","Proven neonatal infection while in the NICU","\"sepsis\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient.\r\nNo marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"N","For multiple pregnancies an event was reported if either or both infants had the outcome. ","PN",null,"PY",null,"PN",null,"Some concerns","Some concerns","For multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. \r\n\r\n",null,null,"N","Outcome determined from case records. ","PN",null,"N","Deidentified charts underwent blinded central review by 2 neonatologists. ","NA",null,"NA",null,"Low","Low","Outcome determined from case records. \r\n\r\nDeidentified charts underwent blinded central review by 2 neonatologists. \r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was defined in protocol documentation. ","N","Outcome defined in protocol document. ","N","Absolute number of outcomes was eligible for inclusion. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was defined in protocol documentation. ",null,null,"Some concerns","Some concerns","Some concerns as for multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. "]
["2022/01/15 08.50","WAP2006F7","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","ROP","ROP","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient.\r\nNo marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"N","For multiple pregnancies an event was reported if either or both infants had the outcome. ","PN",null,"PY",null,"PN",null,"Some concerns","Some concerns","For multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. \r\n\r\n",null,null,"PN","It was not described how ROP was assessed. Outcome determined from case records. ","PN",null,"N","Deidentified charts underwent blinded central review by 2 neonatologists. ","NA",null,"NA",null,"Low","Low","It was not described how ROP was assessed. Outcome determined from case records. \r\n\r\nDeidentified charts underwent blinded central review by 2 neonatologists. \r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ","PN","Outcome and timeframe clearly defined in methods. ","N","Absolute number of outcomes was eligible for inclusion. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ",null,null,"Some concerns","Some concerns","Some concerns as for multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. "]
["2022/01/15 08.51","WAP2006F10","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","PDA","PDA","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient.\r\nNo marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"N","For multiple pregnancies an event was reported if either or both infants had the outcome. ","PN",null,"PY",null,"PN",null,"Some concerns","Some concerns","For multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. \r\n\r\n",null,null,"PN","Outcome determined from case records. ","PN",null,"N","Deidentified charts underwent blinded central review by 2 neonatologists. ","NA",null,"NA",null,"Low","Low","Outcome determined from case records. \r\n\r\nDeidentified charts underwent blinded central review by 2 neonatologists. \r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ","PN","the definition of PDA used was unclear. ","N","Absolute number of outcomes was eligible for inclusion. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ",null,null,"Some concerns","Some concerns","Some concerns as for multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. "]
["2022/01/15 08.55","WAP2006F12","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","Use of invasive respiratory support ","on ventilator support","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient.\r\nNo marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"N","For multiple pregnancies an event was reported if either or both infants had the outcome. ","PN",null,"PY",null,"PN",null,"Some concerns","Some concerns","For multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. \r\n\r\n",null,null,"PN","Based on care provided by the blinded treating team.","PN",null,"N","Deidentified charts underwent blinded central review by 2 neonatologists. ","NA",null,"NA",null,"Low","Low","Based on care provided by the blinded treating team.\r\n\r\nDeidentified charts underwent blinded central review by 2 neonatologists. \r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation as part of the composite outcome. ","PN","Outcome not defined in methods but there are limited ways of defining this outcome. ","N","Absolute number of outcomes was eligible for inclusion. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation as part of the composite outcome. ",null,null,"Some concerns","Some concerns","Some concerns as for multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. "]
["2022/01/15 08.55","WAP2006F13","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","Use of non-invasive respiratory support ","any CPAP","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient.\r\nNo marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"N","For multiple pregnancies an event was reported if either or both infants had the outcome. ","PN",null,"PY",null,"PN",null,"Some concerns","Some concerns","For multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. \r\n\r\n",null,null,"PN","Based on care provided by the blinded treating team.","PN",null,"N","Deidentified charts underwent blinded central review by 2 neonatologists. ","NA",null,"NA",null,"Low","Low","Based on care provided by the blinded treating team.\r\n\r\nDeidentified charts underwent blinded central review by 2 neonatologists. \r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation as part of the composite outcome. ","PN","Outcome not defined in methods but there are limited ways of defining this outcome. ","N","Absolute number of outcomes was eligible for inclusion. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation as part of the composite outcome. ",null,null,"Some concerns","Some concerns","Some concerns as for multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. "]
["2022/01/15 08.55","WAP2006F15","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","use of surfactant","use of surfactant","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient.\r\nNo marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"N","For multiple pregnancies an event was reported if either or both infants had the outcome. ","PN",null,"PY",null,"PN",null,"Some concerns","Some concerns","For multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. \r\n\r\n",null,null,"N","Based on care provided by the blinded treating team.","PN",null,"N","Deidentified charts underwent blinded central review by 2 neonatologists. ","NA",null,"NA",null,"Low","Low","Based on care provided by the blinded treating team.\r\n\r\nDeidentified charts underwent blinded central review by 2 neonatologists. \r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation as part of the composite outcome. ","PN","Outcome not defined in methods but there are limited ways of defining this outcome. ","N","Absolute number of outcomes was eligible for inclusion. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation as part of the composite outcome. ",null,null,"Some concerns","Some concerns","Some concerns as for multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. "]
["2022/01/15 09.02","WAP2006F18","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","Air leak syndrome","pneumothorax","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient.\r\nNo marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"N","For multiple pregnancies an event was reported if either or both infants had the outcome. ","PN",null,"PY",null,"PN",null,"Some concerns","Some concerns","For multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. \r\n\r\n",null,null,"PN","Outcome determined from case records. ","PN",null,"N","Deidentified charts underwent blinded central review by 2 neonatologists. ","NA",null,"NA",null,"Low","Low","Outcome determined from case records. \r\n\r\nDeidentified charts underwent blinded central review by 2 neonatologists. \r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was not specified in protocol documentation. Outcome definition and analysis unlikely to have been selected based on results.","PN","Outcome not defined in methods but unlikely to be defined in different ways. ","N","Absolute number of outcomes was eligible for inclusion. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was not specified in protocol documentation. Outcome definition and analysis unlikely to have been selected based on results.",null,null,"Some concerns","Some concerns","Some concerns as for multiple pregnancies an event was reported if either or both infants had the outcome. This potentially biases the event incidence and treatment effect estimate. "]
["2022/01/15 09.05","WAP2006L1","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","Birthweight","Birthweight and multiples of the median","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient.\r\nNo marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"Y",">99% had data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low",">99% had data for this outcome. \r\n\r\n\r\n",null,null,"N",null,"N",null,"N","Deidentified charts underwent blinded central review by 2 neonatologists. ","NA",null,"NA",null,"Low","Low","\r\n\r\nDeidentified charts underwent blinded central review by 2 neonatologists. \r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ","PN","Outcome and timeframe clearly defined. ","PN","Multiple of the median was noted as prespecified in the methods. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ",null,null,"Low","Low","Low risk of bias for all domains"]
["2022/01/15 09.42","WAP2006L2","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","Interval between trial entry and birth","latency from randomisation to delivery","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient.\r\nNo marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"Y",">99% had data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low",">99% had data for this outcome. \r\n\r\n\r\n",null,null,"N",null,"PN",null,"N","Deidentified charts underwent blinded central review by 2 neonatologists. ","NA",null,"NA",null,"Low","Low","\r\n\r\nDeidentified charts underwent blinded central review by 2 neonatologists. \r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ","PN",null,"N","Only mean and SD recorded and eligible for inclusion. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ",null,null,"Low","Low","Low risk of bias for all domains"]
["2022/01/15 09.34","WAP2006L3","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","HC at birth","HC at birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient.\r\nNo marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"Y",">99% had data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low",">99% had data for this outcome. \r\n\r\n\r\n",null,null,"N",null,"N",null,"N","Deidentified charts underwent blinded central review by 2 neonatologists. ","NA",null,"NA",null,"Low","Low","\r\n\r\nDeidentified charts underwent blinded central review by 2 neonatologists. \r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ","PN","Outcome and timeframe clearly defined in methods. ","PN",null,"Low","Low","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. \r\n",null,null,"Low","Low","Low risk of bias for all domains"]
["2022/01/15 09.03","WAP2006L4","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","length at birth","length at birth and multiples of the median","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient.\r\nNo marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"Y",">99% had data for this outcome. ","NA",null,"NA",null,"NA",null,"Low","Low",">99% had data for this outcome. \r\n\r\n\r\n",null,null,"N",null,"N",null,"N","Deidentified charts underwent blinded central review by 2 neonatologists. ","NA",null,"NA",null,"Low","Low","\r\n\r\nDeidentified charts underwent blinded central review by 2 neonatologists. \r\n\r\n",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation as part of the composite outcome. ","PN","Outcome and timeframe clearly defined in methods. ","PN","Multiple of the median was noted as prespecified in the methods. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation as part of the composite outcome. ",null,null,"Low","Low","Low risk of bias for all domains"]
["2022/01/15 09.34","WAP2006L14","AW&CM","Wapner2006",2675283,"Betamethasone","Placebo","measures of HPA axis function","cord cortisol concentration","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","PY","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. ","N","Randomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient. No marked imbalance of baseline characteristics. ","Low","Low","Numbered kits were prepared using randomisation sequences created by an independent data co-ordinating centre. Sequences were generated using the urn design. Woman were assigned to the next sequentially-numbered kit. \r\nRandomisation was stratified by clinical centre, type of qualifying course and status as inpatient or outpatient.\r\nNo marked imbalance of baseline characteristics. ",null,null,"PN","PN","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. ","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","Betamethasone or identical appearing placebo was prepared by a centralised research pharmacy. \r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"PN","Data available for approximately 76% of pregnancies but was intended as a subset of the overall study.","PN","Sensitivity analysis not performed. ","PY","Proportion of missing data was similar between intervention and placebo groups. ","PN",null,"Some concerns","Some concerns","Data available for approximately 76% of pregnancies. \r\nSensitivity analysis not performed. \r\nProportion of missing data was similar between intervention and placebo groups. \r\n",null,null,"PY","Cord cortisol is a poor measure of HPA axis; should at least be total glucocorticoid activity","PN",null,"NA",null,"NA",null,"NA",null,"High","Some concerns","\r\nBlinding of assessors not described for this outcome but was likely, and results unlikely to be influenced by knowledge of treatment allocation. Measurement of cord cortisol is not a reliable measure of HPA axis function.",null,null,"PY","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ","PN"," ","N","Only mean and SD recorded and eligible for inclusion. ","Low","Low","Protocol with planned statistical analysis was available for review. Outcome was specified in protocol documentation. ",null,null,"Some concerns","Some concerns","Some concerns as data available for only 76% of pregnancies but the proportion of missing data was similar between intervention and placebo groups. Measurement of cord cortisol is not a reliable measure of HPA axis function."]
["2022/01/16 08.34","McE2010A1","AW&JH","McEvoy2010",2675256,"Betamethasone","Placebo","Fetal or neonatal or infant death","fetal death +neonatal death","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. ","N","Stratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons). No marked imbalance of baseline characteristics. ","Low","Low","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. \r\nStratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons).\r\nNo marked imbalance of baseline characteristics. ",null,null,"N","N","\"All patients, investigators and care providers were unaware of the treatment allocation.\"","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","\"All patients, investigators and care providers were unaware of the treatment allocation.\"\r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"Y","Data available for this outcome for all except one infant. ","NA",null,"NA",null,"NA",null,"Low","Low","Data available for this outcome for all except one infant. \r\n\r\n\r\n",null,null,"N",null,"N",null,"N","Investigators were unaware of treatment allocation. ","NA",null,"NA",null,"Low","Low","\r\n\r\nInvestigators were unaware of treatment allocation. \r\n\r\n",null,null,"NI","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.","PN",null,"PN","Absolute numbers of events were recorded. ","Some concerns","Low","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 08.34","McE2010A2","AW&JH","McEvoy2010",2675256,"Betamethasone","Placebo","fetal death","fetal death","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. ","N","Stratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons). No marked imbalance of baseline characteristics. ","Low","Low","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. \r\nStratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons).\r\nNo marked imbalance of baseline characteristics. ",null,null,"N","N","\"All patients, investigators and care providers were unaware of the treatment allocation.\"","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","\"All patients, investigators and care providers were unaware of the treatment allocation.\"\r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"Y","No missing data for this outcome","NA",null,"NA",null,"NA",null,"Low","Low","No missing data for this outcome. \r\n\r\n\r\n",null,null,"N",null,"N",null,"N","Investigators were unaware of treatment allocation. ","NA",null,"NA",null,"Low","Low","\r\n\r\nInvestigators were unaware of treatment allocation. \r\n\r\n",null,null,"NI","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.","PN",null,"PN","Absolute numbers of events were recorded. ","Some concerns","Low","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 08.34","McE2010A3","AW&JH","McEvoy2010",2675256,"Betamethasone","Placebo","neonatal death","neonatal death","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. ","N","Stratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons). No marked imbalance of baseline characteristics. ","Low","Low","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. \r\nStratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons).\r\nNo marked imbalance of baseline characteristics. ",null,null,"N","N","\"All patients, investigators and care providers were unaware of the treatment allocation.\"","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","\"All patients, investigators and care providers were unaware of the treatment allocation.\"\r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"Y","Data available for this outcome for all except one infant. ","NA",null,"NA",null,"NA",null,"Low","Low","Data available for this outcome for all except one infant. ",null,null,"N",null,"N",null,"N","Investigators were unaware of treatment allocation. ","NA",null,"NA",null,"Low","Low","\r\n\r\nInvestigators were unaware of treatment allocation. \r\n\r\n",null,null,"NI","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.","PN",null,"PN","Absolute numbers of events were recorded. ","Some concerns","Low","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 08.34","McE2010A5","AW&JH","McEvoy2010",2675256,"Betamethasone","Placebo","RDS","RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. ","N","Stratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons). No marked imbalance of baseline characteristics. ","Low","Low","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. \r\nStratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons).\r\nNo marked imbalance of baseline characteristics. ",null,null,"N","N","\"All patients, investigators and care providers were unaware of the treatment allocation.\"","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","\"All patients, investigators and care providers were unaware of the treatment allocation.\"\r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"Y","Data available for this outcome for all except one infant. ","NA",null,"NA",null,"NA",null,"Low","Low","Data available for this outcome for all except one infant. \r\n\r\n\r\n",null,null,"N","RDS assessment based on clinical signs, radiographic evidence and oxygen requirement. ","PN",null,"N","Investigators were unaware of treatment allocation. ",null,null,null,null,"Low","Low","RDS assessment based on clinical signs, radiographic evidence and oxygen requirement. \r\n\r\nInvestigators were unaware of treatment allocation. \r\n\r\n",null,null,"NI","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.","PN","RDS definition was clearly defined in methods. ","N",null,"Some concerns","Low","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 08.39","McE2010A8","AW&JH","McEvoy2010",2675256,"Betamethasone","Placebo","Chronic lung disease","Chronic lung disease","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. ","N","Stratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons). No marked imbalance of baseline characteristics. ","Low","Low","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. \r\nStratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons).\r\nNo marked imbalance of baseline characteristics. ",null,null,"N","N","\"All patients, investigators and care providers were unaware of the treatment allocation.\"","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","\"All patients, investigators and care providers were unaware of the treatment allocation.\"\r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"Y","Data available for this outcome for all except one infant. ","NA",null,"NA",null,"NA",null,"Low","Low","Data available for this outcome for all except one infant. \r\n\r\n\r\n",null,null,"NI","Outcome was not defined in methods. ","PN",null,"N","Investigators were unaware of treatment allocation. ",null,null,null,null,"Low","Low","Outcome was not defined in methods. \r\n\r\nInvestigators were unaware of treatment allocation. \r\n\r\n",null,null,"NI","SAP and protocol were not available for review. Outcome was not in trial registration documentation. The outcome definition was unclear in the methods with multiple possible definitions available. ","NI","Outcome definition unclear and multiple possibilities. ","PN",null,"Some concerns","Some concerns","SAP and protocol were not available for review. Outcome was not in trial registration documentation. The outcome definition was unclear in the methods with multiple possible definitions available. \r\n\r\n",null,null,"Some concerns","Some concerns","Some concerns as outcome was not defined in methods and multiple possible definitions exist. SAP was not available for review but an interim analysis was performed by an independent data safety monitoring committee made prespecified analysis plans likely. "]
["2022/01/16 08.35","McE2010F1","AW&JH","McEvoy2010",2675256,"Betamethasone","Placebo","GA at birth","Mean GA at birth, very preterm birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. ","N","Stratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons). No marked imbalance of baseline characteristics. ","Low","Low","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. \r\nStratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons).\r\nNo marked imbalance of baseline characteristics. ",null,null,"N","N","\"All patients, investigators and care providers were unaware of the treatment allocation.\"","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","\"All patients, investigators and care providers were unaware of the treatment allocation.\"\r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"Y","Data available for this outcome for all except one infant. ","NA",null,"NA",null,"NA",null,"Low","Low","Data available for this outcome for all except one infant. \r\n\r\n\r\n",null,null,"N","Method of gestational age assessment not stated but unlikely to have differed between groups. ","N",null,"N","Investigators were unaware of treatment allocation. ",null,null,null,null,"Low","Low","Method of gestational age assessment not stated but unlikely to have differed between groups. \r\n\r\nInvestigators were unaware of treatment allocation. \r\n\r\n",null,null,"NI","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.","N",null,"N",null,"Some concerns","Low","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 08.35","McE2010F2","AW&JH","McEvoy2010",2675256,"Betamethasone","Placebo","SGA","SGA","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. ","N","Stratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons). No marked imbalance of baseline characteristics. ","Low","Low","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. \r\nStratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons).\r\nNo marked imbalance of baseline characteristics. ",null,null,"N","N","\"All patients, investigators and care providers were unaware of the treatment allocation.\"","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","\"All patients, investigators and care providers were unaware of the treatment allocation.\"\r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"Y","Data available for this outcome for all except one infant. ","NA",null,"NA",null,"NA",null,"Low","Low","Data available for this outcome for all except one infant. ",null,null,"N","Method of measurement likely standard and unlikely to have differed between treatment groups. ","N",null,"N","Investigators were unaware of treatment allocation. ",null,null,null,null,"Low","Low","Method of measurement likely standard and unlikely to have differed between treatment groups. \r\n\r\nInvestigators were unaware of treatment allocation. \r\n\r\n",null,null,"NI","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.","PN","Definition of SGA used was standard. ","PN",null,"Some concerns","Low","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.\r\nDefinition of SGA used was standard. \r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 08.35","McE2010F12","AW&JH","McEvoy2010",2675256,"Betamethasone","Placebo","Use of invasive respiratory support ","mechanical ventilation","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. ","N","Stratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons). No marked imbalance of baseline characteristics. ","Low","Low","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. \r\nStratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons).\r\nNo marked imbalance of baseline characteristics. ",null,null,"N","N","\"All patients, investigators and care providers were unaware of the treatment allocation.\"","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","\"All patients, investigators and care providers were unaware of the treatment allocation.\"\r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"Y","Data available for this outcome for all except one infant. ","NA",null,"NA",null,"NA",null,"Low","Low","Data available for this outcome for all except one infant. \r\n\r\n\r\n",null,null,"N","Outcome based on treatment administered by the treating team, who were blinded to allocation. ","PN",null,"N","Investigators were unaware of treatment allocation. ",null,null,null,null,"Low","Low","Outcome based on treatment administered by the treating team, who were blinded to allocation. \r\n\r\nInvestigators were unaware of treatment allocation. \r\n\r\n",null,null,"NI","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.","PN","Timing clear in trial registration. ","PN",null,"Some concerns","Low","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 08.35","McE2010F15","AW&JH","McEvoy2010",2675256,"Betamethasone","Placebo","Use of surfactant","Use of surfactant","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. ","N","Stratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons). No marked imbalance of baseline characteristics. ","Low","Low","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. \r\nStratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons).\r\nNo marked imbalance of baseline characteristics. ",null,null,"N","N","\"All patients, investigators and care providers were unaware of the treatment allocation.\"","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","\"All patients, investigators and care providers were unaware of the treatment allocation.\"\r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"Y","Data available for this outcome for all except one infant. ","NA",null,"NA",null,"NA",null,"Low","Low","Data available for this outcome for all except one infant. \r\n\r\n\r\n",null,null,"N","Outcome based on treatment administered by the treating team, who were blinded to allocation. ","PN",null,"N","Investigators were unaware of treatment allocation. ",null,null,null,null,"Low","Low","Outcome based on treatment administered by the treating team, who were blinded to allocation. \r\n\r\nInvestigators were unaware of treatment allocation. \r\n\r\n",null,null,"NI","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.","PN","Timing clear in trial registration. ","PN",null,"Some concerns","Low","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 08.35","McE2010L1","AW&JH","McEvoy2010",2675256,"Betamethasone","Placebo","Birthweight","Birthweight","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. ","N","Stratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons). No marked imbalance of baseline characteristics. ","Low","Low","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. \r\nStratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons).\r\nNo marked imbalance of baseline characteristics. ",null,null,"N","N","\"All patients, investigators and care providers were unaware of the treatment allocation.\"","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","\"All patients, investigators and care providers were unaware of the treatment allocation.\"\r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"Y","Data available for this outcome for all except one infant. ","NA",null,"NA",null,"NA",null,"Low","Low","Data available for this outcome for all except one infant. \r\n\r\n\r\n",null,null,"N","Method of measurement likely standard and unlikely to have differed between treatment groups. ","N",null,"N","Investigators were unaware of treatment allocation. ",null,null,null,null,"Low","Low","Method of measurement likely standard and unlikely to have differed between treatment groups. \r\n\r\nInvestigators were unaware of treatment allocation. \r\n\r\n",null,null,"NI","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.","N",null,"N",null,"Some concerns","Low","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.\r\n",null,null,"Low","Low","Low risk of bias for all domains.  "]
["2022/01/16 08.35","McE2010L2","AW&JH","McEvoy2010",2675256,"Betamethasone","Placebo","Interval between trial entry and birth","mean and SD Interval between trial entry and birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. ","N","Stratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons). No marked imbalance of baseline characteristics. ","Low","Low","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. \r\nStratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons).\r\nNo marked imbalance of baseline characteristics. ",null,null,"N","N","\"All patients, investigators and care providers were unaware of the treatment allocation.\"","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","\"All patients, investigators and care providers were unaware of the treatment allocation.\"\r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"Y","Data available for this outcome for all except one infant. ","NA",null,"NA",null,"NA",null,"Low","Low","Data available for this outcome for all except one infant. \r\n\r\n\r\n",null,null,"N","Outcome was objective. ","PN",null,"N","Investigators were unaware of treatment allocation. ",null,null,null,null,"Low","Low","Outcome was objective. \r\n\r\nInvestigators were unaware of treatment allocation. \r\n\r\n",null,null,"NI","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.","N",null,"PN","Median was reported in one study report but mean and SD in another, however the result was the same for both. ","Some concerns","Low","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.\r\n\r\nMedian was reported in one study report but mean and SD in another, however the result was the same for both. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 08.35","McE2010L3","AW&JH","McEvoy2010",2675256,"Betamethasone","Placebo","Head circumference at birth ","Head circumference at birth ","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. ","N","Stratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons). No marked imbalance of baseline characteristics. ","Low","Low","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. \r\nStratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons).\r\nNo marked imbalance of baseline characteristics. ",null,null,"N","N","\"All patients, investigators and care providers were unaware of the treatment allocation.\"","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","\"All patients, investigators and care providers were unaware of the treatment allocation.\"\r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"PY","Neonatal data missing for 1 infant","NA",null,"NA",null,"NA",null,"Low","Low","Neonatal data missing for 1 infant\r\n\r\n\r\n",null,null,"N","Method of measurement likely standard and unlikely to have differed between treatment groups. ","PN",null,"N","Investigators were unaware of treatment allocation. ",null,null,null,null,"Low","Low","Method of measurement likely standard and unlikely to have differed between treatment groups. \r\n\r\nInvestigators were unaware of treatment allocation. \r\n\r\n",null,null,"NI","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.","N",null,"N",null,"Some concerns","Low","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 08.35","McE2010L4","AW&JH","McEvoy2010",2675256,"Betamethasone","Placebo","Length at birth ","Length at birth ","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. ","N","Stratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons). No marked imbalance of baseline characteristics. ","Low","Low","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. \r\nStratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons).\r\nNo marked imbalance of baseline characteristics. ",null,null,"N","N","\"All patients, investigators and care providers were unaware of the treatment allocation.\"","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","\"All patients, investigators and care providers were unaware of the treatment allocation.\"\r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"Y","Neonatal data missing for 1 infant","NA",null,"NA",null,"NA",null,"Low","Low","Neonatal data missing for 1 infant\r\n\r\n\r\n",null,null,"N","Method of measurement likely standard and unlikely to have differed between treatment groups. ","PN",null,"N","Investigators were unaware of treatment allocation. ",null,null,null,null,"Low","Low","Method of measurement likely standard and unlikely to have differed between treatment groups. \r\n\r\nInvestigators were unaware of treatment allocation. \r\n\r\n",null,null,"NI","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.","N",null,"PN",null,"Some concerns","Low","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 08.52","McE2010L5","AW&JH","McEvoy2010",2675256,"Betamethasone","Placebo","Growth assessments at primary hospital discharge","Growth assessments at primary hospital discharge","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. ","N","Stratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons). No marked imbalance of baseline characteristics. ","Low","Low","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. \r\nStratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons).\r\nNo marked imbalance of baseline characteristics. ",null,null,"N","N","\"All patients, investigators and care providers were unaware of the treatment allocation.\"","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","\"All patients, investigators and care providers were unaware of the treatment allocation.\"\r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"PN","Missing data for 6-12% across growth assessments ","N","No sensitivity analysis performed. ","PY",null,"PN",null,"Some concerns","Some concerns","Missing data for 6-12% across growth assessments without explanation. No sensitivity analysis performed. Loss differed between groups.\r\n",null,null,"N","Method of measurement likely standard and unlikely to have differed between treatment groups. ","PN",null,"N","Investigators were unaware of treatment allocation. ",null,null,null,null,"Low","Low","Method of measurement likely standard and unlikely to have differed between treatment groups. \r\n\r\nInvestigators were unaware of treatment allocation. \r\n\r\n",null,null,"NI","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.","N","Timeframe of assessments clear from registration document and methods. ","PN",null,"Some concerns","Low","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.",null,null,"Some concerns","Some concerns","Some concerns as proportion of missing data is high for assessments done at discharge and may have been related to health status. "]
["2022/01/16 08.36","McE2010L6","AW&JH","McEvoy2010",2675256,"Betamethasone","Placebo","Growth assessments at infant follow-up ","Growth assessments at infant follow-up 1-2years","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. ","N","Stratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons). No marked imbalance of baseline characteristics. ","Low","Low","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. \r\nStratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons).\r\nNo marked imbalance of baseline characteristics. ",null,null,"N","N","\"All patients, investigators and care providers were unaware of the treatment allocation.\"","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","\"All patients, investigators and care providers were unaware of the treatment allocation.\"\r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"N","Data available for 62/113(55%) for HC and 75/113(66%) for other measurements. ","N","No sensitivity analysis performed. ","PY",null,"PN",null,"Some concerns","High","Data available for 62/113(55%) for HC and 75/113(66%) for other measurements. \r\nNo sensitivity analysis performed. \r\nHigh risk due to high levels of loss to follow up, although levels of missing data were similar across the two groups. \r\n",null,null,"N","Method of measurement likely standard and unlikely to have differed between treatment groups. ","PN",null,"N","Investigators were unaware of treatment allocation. ",null,null,null,null,"Low","Low","Method of measurement likely standard and unlikely to have differed between treatment groups. \r\n\r\nInvestigators were unaware of treatment allocation. \r\n\r\n",null,null,"NI","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.","N","Timeframe of assessments clear from registration document and methods. ","PN",null,"Some concerns","Low","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.\r\n",null,null,"High","High","High risk due to very significant levels of loss to follow up at this early stage of follow up, although levels of missing data were similar across the two groups. \r\n\r\n"]
["2022/01/16 08.36","McE2010L8","AW&JH","McEvoy2010",2675256,"Betamethasone","Placebo","Duration of invasive respiratory support","Duration of mechanical ventilation, mean and SD calculated from median and IQR","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. ","N","Stratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons). No marked imbalance of baseline characteristics. ","Low","Low","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. \r\nStratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons).\r\nNo marked imbalance of baseline characteristics. ",null,null,"N","N","\"All patients, investigators and care providers were unaware of the treatment allocation.\"","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","\"All patients, investigators and care providers were unaware of the treatment allocation.\"\r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"Y","Neonatal data missing for 1 infant","NA",null,"NA",null,"NA",null,"Low","Low","Neonatal data missing for 1 infant\r\n\r\n\r\n",null,null,"N","Outcome based on treatment administered by the treating team, who were blinded to allocation. ","PN",null,"N","Investigators were unaware of treatment allocation. ",null,null,null,null,"Low","Low","Outcome based on treatment administered by the treating team, who were blinded to allocation. \r\n\r\nInvestigators were unaware of treatment allocation. \r\n\r\n",null,null,"NI","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.","N",null,"PN",null,"Some concerns","Low","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 08.36","McE2010L10","AW&JH","McEvoy2010",2675256,"Betamethasone","Placebo","Duration of oxygen supplementation ","Duration of oxygen supplementation, calculated mean and SD","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. ","N","Stratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons). No marked imbalance of baseline characteristics. ","Low","Low","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. \r\nStratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons).\r\nNo marked imbalance of baseline characteristics. ",null,null,"N","N","\"All patients, investigators and care providers were unaware of the treatment allocation.\"","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","\"All patients, investigators and care providers were unaware of the treatment allocation.\"\r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"Y","Neonatal data missing for 1 infant","NA",null,"NA",null,"NA",null,"Low","Low","Neonatal data missing for 1 infant\r\n\r\n\r\n",null,null,"N","Outcome based on treatment administered by the treating team, who were blinded to allocation. ","PN",null,"N","Investigators were unaware of treatment allocation. ",null,null,null,null,"Low","Low","Outcome based on treatment administered by the treating team, who were blinded to allocation. \r\n\r\nInvestigators were unaware of treatment allocation. \r\n\r\n",null,null,"NI","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.","N",null,"PN",null,"Some concerns","Low","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/16 08.36","McE2010Q4","AW&JH","McEvoy2010",2675256,"Betamethasone","Placebo","Length of infant hospitalisation ","Length of infant hospitalisation, calculated mean and SD","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. ","N","Stratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons). No marked imbalance of baseline characteristics. ","Low","Low","Group assignment performed using a randomisation table. A staff pharmacist performed randomisation and study drug preparation at each institution. \r\nStratification was performed for ≤ 28 versus > 28 weeks' gestation and for multiple gestation (twins versus singletons).\r\nNo marked imbalance of baseline characteristics. ",null,null,"N","N","\"All patients, investigators and care providers were unaware of the treatment allocation.\"","NA",null,"NA",null,"NA",null,"Y","Intention-to-treat-analysis","NA",null,"Low","Low","\"All patients, investigators and care providers were unaware of the treatment allocation.\"\r\n\r\n\r\n\r\nIntention-to-treat-analysis\r\n",null,null,"PY","Neonatal data missing for 1 infant","NA",null,"NA",null,"NA",null,"Low","Low","Neonatal data missing for 1 infant\r\n\r\n\r\n",null,null,"N",null,"N",null,"N","Investigators were unaware of treatment allocation. ",null,null,null,null,"Low","Low","\r\n\r\nInvestigators were unaware of treatment allocation. \r\n\r\n",null,null,"NI","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.","N",null,"PN",null,"Some concerns","Low","SAP and protocol were not available for review. Outcome was not in trial registration documentation but the outcome definition and analysis was unlikely to have been selected based on results.\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/12 08.22","MAZ2008A1","AW&CM","Mazumder2008",2675250,"Betamethasone","Placebo","fetal or neonatal or infant death","fetal death+neonatal death","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. ","N","Limited baseline characteristics were recorded. ","Low","Low","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. \r\nLimited baseline characteristics were recorded. ",null,null,"Y","Y","The trial was open-label. ","PN","No deviations from the intended intervention were reported.","NA",null,"NA",null,"N","Methods did not specify if analysis was by intention to treat or per protocol. ","PN",null,"Some concerns","Some concerns","The trial was open-label. \r\nNo deviations from the intended intervention were reported.\r\n\r\n\r\nMethods did not specify if analysis was by intention to treat or per protocol. \r\n",null,null,"Y","One mother with a singleton pregnancy was lost to follow up before delivery.","NA",null,"NA",null,"NA",null,"Low","Low","One mother with a singleton pregnancy was lost to follow up before delivery.",null,null,"N",null,"PN",null,"PY","This was an open-label trail and blinding of outcome assessors was not described. ","N","Assessment of mortality not able to be influenced by knowledge of intervention received. ","NA",null,"Low","Low","\r\n\r\nThis was an open-label trail and blinding of outcome assessors was not described. \r\nAssessment of mortality not able to be influenced by knowledge of intervention received. \r\n",null,null,"NI","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. ","N",null,"N",null,"Some concerns","Some concerns","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. \r\n\r\n",null,null,"Some concerns","Some concerns","Some concerns overall as there were some concerns of risk of bias for deviations from intended interventions because the trial was open label and some concerns of bias in selection of the reported result because of the limited detail of analysis methods and outcomes. \n\r\n"]
["2021/09/02 10.21","MAZ2008A2","AW&CM","Mazumder2008",2675250,"Betamethasone","Placebo","fetal death","fetal death","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. ","N","Limited baseline characteristics were recorded. ","Low","Low","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. \r\nLimited baseline characteristics were recorded. ",null,null,"Y","Y","The trial was open-label. ","PN","No deviations from the intended intervention were reported.","NA",null,"NA",null,"N","Methods did not specify if analysis was by intention to treat or per protocol. ","PN",null,"Some concerns","Some concerns","The trial was open-label. \r\nNo deviations from the intended intervention were reported.\r\n\r\n\r\nMethods did not specify if analysis was by intention to treat or per protocol. \r\n",null,null,"Y","One mother with a singleton pregnancy was lost to follow up before delivery.","NA",null,"NA",null,"NA",null,"Low","Low","One mother with a singleton pregnancy was lost to follow up before delivery.\r\n\r\n\r\n",null,null,"N",null,"PN",null,"PY","This was an open-label trail and blinding of outcome assessors was not described. ","N","Assessment of mortality not able to be influenced by knowledge of intervention received. ","NA",null,"Low","Low","\r\n\r\nThis was an open-label trail and blinding of outcome assessors was not described. \r\nAssessment of mortality not able to be influenced by knowledge of intervention received. \r\n",null,null,"NI","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. ","N",null,"N",null,"Some concerns","Some concerns","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. \r\n\r\n",null,null,"Some concerns","Some concerns","Some concerns overall as there were some concerns of risk of bias for deviations from intended interventions because the trial was open label and some concerns of bias in selection of the reported result because of the limited detail of analysis methods and outcomes. \n\r\n"]
["2021/09/02 10.27","MAZ2008A3","AW&CM","Mazumder2008",2675250,"Betamethasone","Placebo","neonatal death","neonatal death","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. ","N","Limited baseline characteristics were recorded. ","Low","Low","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. \r\nLimited baseline characteristics were recorded. ",null,null,"Y","Y","The trial was open-label. ","PN","No deviations from the intended intervention were reported.","NA",null,"NA",null,"N","Methods did not specify if analysis was by intention to treat or per protocol. ","PN",null,"Some concerns","Some concerns","The trial was open-label. \r\nNo deviations from the intended intervention were reported.\r\n\r\n\r\nMethods did not specify if analysis was by intention to treat or per protocol. \r\n",null,null,"Y","One mother with a singleton pregnancy was lost to follow up before delivery.","NA",null,"NA",null,"NA",null,"Low","Low","One mother with a singleton pregnancy was lost to follow up before delivery.\r\n\r\n\r\n",null,null,"N",null,"PN",null,"PY","This was an open-label trial and blinding of outcome assessors was not described. ","N","Assessment of mortality not able to be influenced by knowledge of intervention received. ","NA",null,"Low","Low","\r\n\r\nThis was an open-label trial and blinding of outcome assessors was not described. \r\nAssessment of mortality not able to be influenced by knowledge of intervention received. \r\n",null,null,"NI","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. ","N",null,"N",null,"Some concerns","Some concerns","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. \r\n\r\n",null,null,"Some concerns","Some concerns","Some concerns overall as there were some concerns of risk of bias for deviations from intended interventions because the trial was open label and some concerns of bias in selection of the reported result because of the limited detail of analysis methods and outcomes. \n\r\n"]
["2022/01/12 08.37","MAZ2008A5","AW&CM","Mazumder2008",2675250,"Betamethasone","Placebo","RDS","RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. ","N","Limited baseline characteristics were recorded. ","Low","Low","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. \r\nLimited baseline characteristics were recorded. ",null,null,"Y","Y","The trial was open-label. ","PN","No deviations from the intended intervention were reported.","NA",null,"NA",null,"N","Methods did not specify if analysis was by intention to treat or per protocol. ","PN",null,"Some concerns","Some concerns","The trial was open-label. \r\nNo deviations from the intended intervention were reported.\r\n\r\n\r\nMethods did not specify if analysis was by intention to treat or per protocol. \r\n",null,null,"Y","One mother with a singleton pregnancy was lost to follow up before delivery.","NA",null,"NA",null,"NA",null,"Low","Low","One mother with a singleton pregnancy was lost to follow up before delivery.\r\n\r\n\r\n",null,null,"N",null,"PY","This was an open-label trial and blinding of outcome assessors was not described. Outcome ascertainment able to be influenced by knowledge of treatment allocation. ","NA",null,"NA",null,"NA",null,"High","High","\r\nThis was an open-label trial and blinding of outcome assessors was not described. Outcome ascertainment able to be influenced by knowledge of treatment allocation. \r\n\r\n\r\n",null,null,"NI","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. ","PN",null,"PN",null,"Some concerns","Some concerns","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. \r\n\r\n",null,null,"High","High","High risk overall as there were some concerns of risk of bias for deviations from intended interventions because the trial was open label, some concerns of bias in selection of the reported result due to limited detail of analysis methods and outcomes and high of risk of bias for measurement of the outcome as  blinding of outcome assessors was not described for an outcome likely to be influenced by knowledge of allocation. \r\n\r\n\r\n\r\n"]
["2021/10/11 12.13","MAZ2008A6","AW&CM","Mazumder2008",2675250,"Betamethasone","Placebo","Severe RDS","Severe RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. ","N","Limited baseline characteristics were recorded. ","Low","Low","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. \r\nLimited baseline characteristics were recorded. ",null,null,"Y","Y","The trial was open-label. ","PN","No deviations from the intended intervention were reported.","NA",null,"NA",null,"N","Methods did not specify if analysis was by intention to treat or per protocol. ","PN",null,"Some concerns","Some concerns","The trial was open-label. \r\nNo deviations from the intended intervention were reported.\r\n\r\n\r\nMethods did not specify if analysis was by intention to treat or per protocol. \r\n",null,null,"Y","One mother with a singleton pregnancy was lost to follow up before delivery.","NA",null,"NA",null,"NA",null,"Low","Low","One mother with a singleton pregnancy was lost to follow up before delivery.\r\n\r\n\r\n",null,null,"N",null,"PN",null,"PY","This was an open-label trial and blinding of outcome assessors was not described. ","PN","Assessment unlikely to be affected by knowledge of allocation as outcome grading was objective (based on the need for mechanical ventilation for 12 hours). ","NA",null,"Low","Low","\r\n\r\nThis was an open-label trial and blinding of outcome assessors was not described. \r\nAssessment unlikely to be affected by knowledge of allocation as outcome grading was objective (based on the need for mechanical ventilation for 12 hours). \r\n",null,null,"NI","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. ","PN",null,"PN",null,"Some concerns","Some concerns","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. \r\n\r\n",null,null,"Some concerns","Some concerns","Some concerns overall as there were some concerns of risk of bias for deviations from intended interventions because the trial was open label and some concerns of bias in selection of the reported result because of the limited detail of analysis methods and outcomes. "]
["2021/09/02 10.38","MAZ2008A7","AW&CM","Mazumder2008",2675250,"Betamethasone","Placebo","Severe lung disease","Severe RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. ","N","Limited baseline characteristics were recorded. ","Low","Low","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. \r\nLimited baseline characteristics were recorded. ",null,null,"Y","Y","The trial was open-label. ","PN","No deviations from the intended intervention were reported.","NA",null,"NA",null,"N","Methods did not specify if analysis was by intention to treat or per protocol. ","PN",null,"Some concerns","Some concerns","The trial was open-label. \r\nNo deviations from the intended intervention were reported.\r\n\r\n\r\nMethods did not specify if analysis was by intention to treat or per protocol. \r\n",null,null,"Y","One mother with a singleton pregnancy was lost to follow up before delivery.","NA",null,"NA",null,"NA",null,"Low","Low","One mother with a singleton pregnancy was lost to follow up before delivery.\r\n\r\n\r\n",null,null,"N",null,"PN",null,"PY","This was an open-label trial and blinding of outcome assessors was not described. ","PN","Assessment unlikely to be affected by knowledge of allocation as outcome grading was objective and based on the need for mechanical ventilation for 12 hours. ","NA",null,"Low","Low","\r\n\r\nThis was an open-label trial and blinding of outcome assessors was not described. \r\nAssessment unlikely to be affected by knowledge of allocation as outcome grading was objective and based on the need for mechanical ventilation for 12 hours. \r\n",null,null,"NI","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. ","PN",null,"PN",null,"Some concerns","Low","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. \r\n\r\n",null,null,"Some concerns","Some concerns","Some concerns overall as there were some concerns of risk of bias for deviations from intended interventions because the trial was open label and some concerns of bias in selection of the reported result because of the limited detail of analysis methods and outcomes. "]
["2022/01/12 08.38","MAZ2008A8","AW&CM","Mazumder2008",2675250,"Betamethasone","Placebo","chronic lung disease","BPD","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. ","N","Limited baseline characteristics were recorded. ","Low","Low","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. \r\nLimited baseline characteristics were recorded. ",null,null,"Y","Y","The trial was open-label. ","PN","No deviations from the intended intervention were reported.","NA",null,"NA",null,"N","Methods did not specify if analysis was by intention to treat or per protocol. ","PN",null,"Some concerns","Some concerns","The trial was open-label. \r\nNo deviations from the intended intervention were reported.\r\n\r\n\r\nMethods did not specify if analysis was by intention to treat or per protocol. \r\n",null,null,"Y","One mother with a singleton pregnancy was lost to follow up before delivery.","NA",null,"NA",null,"NA",null,"Low","Low","One mother with a singleton pregnancy was lost to follow up before delivery.\r\n\r\n\r\n",null,null,"N",null,"PY","This was an open-label trial and blinding of outcome assessors was not described. The outcome ascertainment is likely to be influenced by knowledge of allocation. ","NA",null,"NA",null,"NA",null,"High","High","\r\nThis was an open-label trial and blinding of outcome assessors was not described. The outcome ascertainment was likely to be influenced by knowledge of allocation. \r\n\r\n\r\n",null,null,"NI","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. ","PN","A published set of standard definitions was used to define this outcome. ","PN",null,"Some concerns","Some concerns","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. \r\n\r\n",null,null,"High","High","High risk overall as there were some concerns of risk of bias for deviations from intended interventions because the trial was open label, some concerns of bias in selection of the reported result due to limited detail of analysis methods and outcomes and high of risk of bias for measurement of the outcome as  blinding of outcome assessors was not described for an outcome likely to be influenced by knowledge of allocation. "]
["2022/01/12 08.38","MAZ2008A10","AW&CM","Mazumder2008",2675250,"Betamethasone","Placebo","IVH","IVH","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. ","N","Limited baseline characteristics were recorded. ","Low","Low","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. \r\nLimited baseline characteristics were recorded. ",null,null,"Y","Y","The trial was open-label. ","PN","No deviations from the intended intervention were reported.","NA",null,"NA",null,"N","Methods did not specify if analysis was by intention to treat or per protocol. ","PN",null,"Some concerns","Some concerns","The trial was open-label. \r\nNo deviations from the intended intervention were reported.\r\n\r\n\r\nMethods did not specify if analysis was by intention to treat or per protocol. \r\n",null,null,"PY","One mother with a singleton pregnancy was lost to follow up before delivery.","NA",null,"NA",null,"NA",null,"Low","Low","One mother with a singleton pregnancy was lost to follow up before delivery.\r\n\r\n\r\n",null,null,"N",null,"PY","This was an open-label trial and blinding of outcome assessors was not described. The outcome ascertainment was likely to be influenced by knowledge of allocation. ","NA",null,"NA",null,"NA",null,"High","High","\r\nThis was an open-label trial and blinding of outcome assessors was not described. The outcome ascertainment was likely to be influenced by knowledge of allocation. \r\n\r\n\r\n",null,null,"NI","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. ","PN","A published set of standard definitions was used to define this outcome. ","PN",null,"Some concerns","Some concerns","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. \r\n\r\n",null,null,"High","High","High risk overall as there were some concerns of risk of bias for deviations from intended interventions because the trial was open label, some concerns of bias in selection of the reported result due to limited detail of analysis methods and outcomes and high of risk of bias for measurement of the outcome as  blinding of outcome assessors was not described for an outcome likely to be influenced by knowledge of allocation. "]
["2022/01/12 08.38","MAZ2008A11","AW&CM","Mazumder2008",2675250,"Betamethasone","Placebo","NEC","NEC","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. ","N","Limited baseline characteristics were recorded. ","Low","Low","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. \r\nLimited baseline characteristics were recorded. ",null,null,"Y","Y","The trial was open-label. ","PN","No deviations from the intended intervention were reported.","NA",null,"NA",null,"N","Methods did not specify if analysis was by intention to treat or per protocol. ","PN",null,"Some concerns","Some concerns","The trial was open-label. \r\nNo deviations from the intended intervention were reported.\r\n\r\n\r\nMethods did not specify if analysis was by intention to treat or per protocol. \r\n",null,null,"Y","One mother with a singleton pregnancy was lost to follow up before delivery.","NA",null,"NA",null,"NA",null,"Low","Low","One mother with a singleton pregnancy was lost to follow up before delivery.\r\n\r\n\r\n",null,null,"N",null,"PY","This was an open-label trial and blinding of outcome assessors was not described. The outcome ascertainment was likely to be influenced by knowledge of allocation. ","NA",null,"NA",null,"NA",null,"High","High","\r\nThis was an open-label trial and blinding of outcome assessors was not described. The outcome ascertainment was likely to be influenced by knowledge of allocation. \r\n\r\n\r\n",null,null,"NI","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. ","PN","A published set of standard definitions was used to define this outcome. ","PN",null,"Some concerns","Some concerns","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. \r\n\r\n",null,null,"High","High","High risk overall as there were some concerns of risk of bias for deviations from intended interventions because the trial was open label, some concerns of bias in selection of the reported result due to limited detail of analysis methods and outcomes and high of risk of bias for measurement of the outcome as  blinding of outcome assessors was not described for an outcome likely to be influenced by knowledge of allocation. "]
["2021/10/11 12.20","MAZ2008A12","AW&CM","Mazumder2008",2675250,"Betamethasone","Placebo","Composite serious outcome ","Severe RDS of death <28days","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. ","N","Limited baseline characteristics were recorded. ","Low","Low","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. \r\nLimited baseline characteristics were recorded. ",null,null,"Y","Y","The trial was open-label. ","PN","No deviations from the intended intervention were reported.","NA",null,"NA",null,"N","Methods did not specify if analysis was by intention to treat or per protocol. ","PN",null,"Some concerns","Some concerns","The trial was open-label. \r\nNo deviations from the intended intervention were reported.\r\n\r\n\r\nMethods did not specify if analysis was by intention to treat or per protocol. \r\n",null,null,"Y","One mother with a singleton pregnancy was lost to follow up before delivery.","NA",null,"NA",null,"NA",null,"Low","Low","One mother with a singleton pregnancy was lost to follow up before delivery.\r\n\r\n\r\n",null,null,"N",null,"PN",null,"PY","This was an open-label trial and blinding of outcome assessors was not described. ","PN","Outcome unlikely to be influenced by knowledge of allocation. ","NA",null,"Low","Low","\r\n\r\nThis was an open-label trial and blinding of outcome assessors was not described. \r\nOutcome unlikely to be influenced by knowledge of allocation. \r\n",null,null,"NI","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. ","PN","Composite outcome was well defined in the methods. ","PN",null,"Some concerns","Some concerns","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. \r\n\r\n",null,null,"Some concerns","Some concerns","Some concerns overall as there were some concerns of risk of bias for deviations from intended interventions because the trial was open label and some concerns of bias in selection of the reported result because of the limited detail of analysis methods and outcomes. "]
["2021/09/02 11.04","MAZ2008F2","AW&CM","Mazumder2008",2675250,"Betamethasone","Placebo","SGA","SGA","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. ","N","Limited baseline characteristics were recorded. ","Low","Low","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. \r\nLimited baseline characteristics were recorded. ",null,null,"Y","Y","The trial was open-label. ","PN","No deviations from the intended intervention were reported.","NA",null,"NA",null,"N","Methods did not specify if analysis was by intention to treat or per protocol. ","PN",null,"Some concerns","Some concerns","The trial was open-label. \r\nNo deviations from the intended intervention were reported.\r\n\r\n\r\nMethods did not specify if analysis was by intention to treat or per protocol. \r\n",null,null,"Y","One mother with a singleton pregnancy was lost to follow up before delivery.","NA",null,"NA",null,"NA",null,"Low","Low","One mother with a singleton pregnancy was lost to follow up before delivery.\r\n\r\n\r\n",null,null,"N",null,"PN",null,"PY","This was an open-label trial and blinding of outcome assessors was not described. ","PN","The outcome is not able to be influenced by knowledge of treatment allocation.","NA",null,"Low","Low","\r\n\r\nThis was an open-label trial and blinding of outcome assessors was not described. \r\nThe outcome is not able to be influenced by knowledge of treatment allocation.\r\n",null,null,"NI","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. ","NI","The definition used for SGA was unclear.","PN",null,"Some concerns","Some concerns","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. \r\n\r\n",null,null,"Some concerns","Some concerns","Some concerns overall as there were some concerns of risk of bias for deviations from intended interventions because the trial was open label and some concerns of bias in selection of the reported result because of the limited detail of analysis methods and outcomes. "]
["2022/01/12 08.38","MAZ2008F5","AW&CM","Mazumder2008",2675250,"Betamethasone","Placebo","Early systemic neonatal infection ","\"early onset sepsis\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. ","N","Limited baseline characteristics were recorded. ","Low","Low","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. \r\nLimited baseline characteristics were recorded. ",null,null,"Y","Y","The trial was open-label. ","PN","No deviations from the intended intervention were reported.","NA",null,"NA",null,"N","Methods did not specify if analysis was by intention to treat or per protocol. ","PN",null,"Some concerns","Some concerns","The trial was open-label. \r\nNo deviations from the intended intervention were reported.\r\n\r\n\r\nMethods did not specify if analysis was by intention to treat or per protocol. \r\n",null,null,"Y","One mother with a singleton pregnancy was lost to follow up before delivery.","NA",null,"NA",null,"NA",null,"Low","Low","One mother with a singleton pregnancy was lost to follow up before delivery.\r\n\r\n\r\n",null,null,"N",null,"PY","This was an open-label trial and blinding of outcome assessors was not described. The outcome ascertainment was likely to be influenced by knowledge of allocation. ","NA",null,"NA",null,"NA",null,"High","High","\r\nThis was an open-label trial and blinding of outcome assessors was not described. The outcome ascertainment was likely to be influenced by knowledge of allocation. \r\n\r\n\r\n",null,null,"NI","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. ","PN","A published set of standard definitions was used to define this outcome. ","PN",null,"Some concerns","Some concerns","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. \r\n\r\n",null,null,"High","High","High risk overall as there were some concerns of risk of bias for deviations from intended interventions because the trial was open label, some concerns of bias in selection of the reported result due to limited detail of analysis methods and outcomes and high of risk of bias for measurement of the outcome as  blinding of outcome assessors was not described for an outcome likely to be influenced by knowledge of allocation. "]
["2022/01/12 08.38","MAZ2008F6","AW&CM","Mazumder2008",2675250,"Betamethasone","Placebo","Late systemic neonatal infection ","\"late onset sepsis\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. ","N","Limited baseline characteristics were recorded. ","Low","Low","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. \r\nLimited baseline characteristics were recorded. ",null,null,"Y","Y","The trial was open-label. ","PN","No deviations from the intended intervention were reported.","NA",null,"NA",null,"N","Methods did not specify if analysis was by intention to treat or per protocol. ","PN",null,"Some concerns","Some concerns","The trial was open-label. \r\nNo deviations from the intended intervention were reported.\r\n\r\n\r\nMethods did not specify if analysis was by intention to treat or per protocol. \r\n",null,null,"Y","One mother with a singleton pregnancy was lost to follow up before delivery.","NA",null,"NA",null,"NA",null,"Low","Low","One mother with a singleton pregnancy was lost to follow up before delivery.\r\n\r\n\r\n",null,null,"N",null,"PY","This was an open-label trial and blinding of outcome assessors was not described. The outcome ascertainment was likely to be influenced by knowledge of allocation. ","NA",null,"NA",null,"NA",null,"High","High","\r\nThis was an open-label trial and blinding of outcome assessors was not described. The outcome ascertainment was likely to be influenced by knowledge of allocation. \r\n\r\n\r\n",null,null,"NI","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. ","PN","A published set of standard definitions was used to define this outcome. ","PN",null,"Some concerns","Some concerns","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. \r\n\r\n",null,null,"High","High","High risk overall as there were some concerns of risk of bias for deviations from intended interventions because the trial was open label, some concerns of bias in selection of the reported result due to limited detail of analysis methods and outcomes and high of risk of bias for measurement of the outcome as  blinding of outcome assessors was not described for an outcome likely to be influenced by knowledge of allocation. "]
["2022/01/12 08.38","MAZ2008F7","AW&CM","Mazumder2008",2675250,"Betamethasone","Placebo","ROP","ROP","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. ","N","Limited baseline characteristics were recorded. ","Low","Low","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. \r\nLimited baseline characteristics were recorded. ",null,null,"Y","Y","The trial was open-label. ","PN","No deviations from the intended intervention were reported.","NA",null,"NA",null,"N","Methods did not specify if analysis was by intention to treat or per protocol. ","PN",null,"Some concerns","Some concerns","The trial was open-label. \r\nNo deviations from the intended intervention were reported.\r\n\r\n\r\nMethods did not specify if analysis was by intention to treat or per protocol. \r\n",null,null,"Y","One mother with a singleton pregnancy was lost to follow up before delivery.","NA",null,"NA",null,"NA",null,"Low","Low","One mother with a singleton pregnancy was lost to follow up before delivery.\r\n\r\n\r\n",null,null,"N",null,"PY","This was an open-label trial and blinding of outcome assessors was not described. The outcome ascertainment was likely to be influenced by knowledge of allocation. ","NA",null,"NA",null,"NA",null,"High","High","\r\nThis was an open-label trial and blinding of outcome assessors was not described. The outcome ascertainment was likely to be influenced by knowledge of allocation. \r\n\r\n\r\n",null,null,"NI","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. ","PN","A published set of standard definitions was used to define this outcome. ","PN",null,"Some concerns","Some concerns","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. \r\n\r\n",null,null,"High","High","High risk overall as there were some concerns of risk of bias for deviations from intended interventions because the trial was open label, some concerns of bias in selection of the reported result due to limited detail of analysis methods and outcomes and high of risk of bias for measurement of the outcome as  blinding of outcome assessors was not described for an outcome likely to be influenced by knowledge of allocation. "]
["2022/01/12 08.38","MAZ2008F8","AW&CM","Mazumder2008",2675250,"Betamethasone","Placebo","PVL","PVL","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. ","N","Limited baseline characteristics were recorded. ","Low","Low","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. \r\nLimited baseline characteristics were recorded. ",null,null,"Y","Y","The trial was open-label. ","PN","No deviations from the intended intervention were reported.","NA",null,"NA",null,"N","Methods did not specify if analysis was by intention to treat or per protocol. ","PN",null,"Some concerns","Some concerns","The trial was open-label. \r\nNo deviations from the intended intervention were reported.\r\n\r\n\r\nMethods did not specify if analysis was by intention to treat or per protocol. \r\n",null,null,"PY","One mother with a singleton pregnancy was lost to follow up before delivery.","NA",null,"NA",null,"NA",null,"Low","Low","One mother with a singleton pregnancy was lost to follow up before delivery.\r\n\r\n\r\n",null,null,"N",null,"PY","This was an open-label trial and blinding of outcome assessors was not described. The outcome ascertainment was likely to be influenced by knowledge of allocation. ","NA",null,"NA",null,"NA",null,"High","High","\r\nThis was an open-label trial and blinding of outcome assessors was not described. The outcome ascertainment was likely to be influenced by knowledge of allocation. \r\n\r\n\r\n",null,null,"NI","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. ","PN","A published set of standard definitions was used to define this outcome. ","PN",null,"Some concerns","Some concerns","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. \r\n\r\n",null,null,"High","High","High risk overall as there were some concerns of risk of bias for deviations from intended interventions because the trial was open label, some concerns of bias in selection of the reported result due to limited detail of analysis methods and outcomes and high of risk of bias for measurement of the outcome as  blinding of outcome assessors was not described for an outcome likely to be influenced by knowledge of allocation. "]
["2022/01/12 08.39","MAZ2008F9","AW&CM","Mazumder2008",2675250,"Betamethasone","Placebo","neonatal encephalopathy","neonatal encephalopathy","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. ","N","Limited baseline characteristics were recorded. ","Low","Low","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. \r\nLimited baseline characteristics were recorded. ",null,null,"Y","Y","The trial was open-label. ","PN","No deviations from the intended intervention were reported.","NA",null,"NA",null,"N","Methods did not specify if analysis was by intention to treat or per protocol. ","PN",null,"Some concerns","Some concerns","The trial was open-label. \r\nNo deviations from the intended intervention were reported.\r\n\r\n\r\nMethods did not specify if analysis was by intention to treat or per protocol. \r\n",null,null,"PY","One mother with a singleton pregnancy was lost to follow up before delivery.","NA",null,"NA",null,"NA",null,"Low","Low","One mother with a singleton pregnancy was lost to follow up before delivery.\r\n\r\n\r\n",null,null,"N",null,"PY","This was an open-label trial and blinding of outcome assessors was not described. The outcome ascertainment was likely to be influenced by knowledge of allocation. ","NA",null,"NA",null,"NA",null,"High","High","\r\nThis was an open-label trial and blinding of outcome assessors was not described. The outcome ascertainment was likely to be influenced by knowledge of allocation. \r\n\r\n\r\n",null,null,"NI","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. ","NI","Definition of neonatal encephalopathy was unclear. ","PN",null,"Some concerns","Some concerns","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. \r\n\r\n",null,null,"High","High","High risk overall as there were some concerns of risk of bias for deviations from intended interventions because the trial was open label, some concerns of bias in selection of the reported result due to limited detail of analysis methods and outcomes and high of risk of bias for measurement of the outcome as  blinding of outcome assessors was not described for an outcome likely to be influenced by knowledge of allocation. "]
["2022/01/12 08.39","MAZ2008F10","AW&CM","Mazumder2008",2675250,"Betamethasone","Placebo","PDA","PDA","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. ","N","Limited baseline characteristics were recorded. ","Low","Low","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. \r\nLimited baseline characteristics were recorded. ",null,null,"Y","Y","The trial was open-label. ","PN","No deviations from the intended intervention were reported.","NA",null,"NA",null,"N","Methods did not specify if analysis was by intention to treat or per protocol. ","PN",null,"Some concerns","Some concerns","The trial was open-label. \r\nNo deviations from the intended intervention were reported.\r\n\r\n\r\nMethods did not specify if analysis was by intention to treat or per protocol. \r\n",null,null,"PY","One mother with a singleton pregnancy was lost to follow up before delivery.","NA",null,"NA",null,"NA",null,"Low","Low","One mother with a singleton pregnancy was lost to follow up before delivery.\r\n\r\n\r\n",null,null,"N",null,"PY","This was an open-label trial and blinding of outcome assessors was not described. The outcome ascertainment was likely to be influenced by knowledge of allocation. ","NA",null,"NA",null,"NA",null,"High","High","\r\nThis was an open-label trial and blinding of outcome assessors was not described. The outcome ascertainment was likely to be influenced by knowledge of allocation. \r\n\r\n\r\n",null,null,"NI","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. ","PN","A published set of standard definitions was used to define this outcome. ","PN",null,"Some concerns","Some concerns","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. \r\n\r\n",null,null,"High","High","High risk overall as there were some concerns of risk of bias for deviations from intended interventions because the trial was open label, some concerns of bias in selection of the reported result due to limited detail of analysis methods and outcomes and high of risk of bias for measurement of the outcome as  blinding of outcome assessors was not described for an outcome likely to be influenced by knowledge of allocation. "]
["2021/10/11 12.31","MAZ2008F15","AW&CM","Mazumder2008",2675250,"Betamethasone","Placebo","Use of surfactant","Use of surfactant","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. ","N","Limited baseline characteristics were recorded. ","Low","Low","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. \r\nLimited baseline characteristics were recorded. ",null,null,"Y","Y","The trial was open-label. ","PN","No deviations from the intended intervention were reported.","NA",null,"NA",null,"N","Methods did not specify if analysis was by intention to treat or per protocol. ","PN",null,"Some concerns","Some concerns","The trial was open-label. \r\nNo deviations from the intended intervention were reported.\r\n\r\n\r\nMethods did not specify if analysis was by intention to treat or per protocol. \r\n",null,null,"PY","One mother with a singleton pregnancy was lost to follow up before delivery.","NA",null,"NA",null,"NA",null,"Low","Low","One mother with a singleton pregnancy was lost to follow up before delivery.\r\n\r\n\r\n",null,null,"N",null,"PN","This was an open-label trial and blinding of outcome assessors was not described. ","Y",null,"PN","The outcome ascertainment was unlikely to be influenced by knowledge of allocation. ","NA",null,"Low","Low","\r\nThis was an open-label trial and blinding of outcome assessors was not described. \r\n\r\nThe outcome ascertainment was unlikely to be influenced by knowledge of allocation. \r\n",null,null,"NI","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. ","PN",null,"PN",null,"Some concerns","Some concerns","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. \r\n\r\n",null,null,"Some concerns","Some concerns","Some concerns overall as there were some concerns of risk of bias for deviations from intended interventions because the trial was open label and some concerns of bias in selection of the reported result because of the limited detail of analysis methods and outcomes. "]
["2021/10/11 12.31","MAZ2008L1","AW&CM","Mazumder2008",2675250,"Betamethasone","Placebo","Birthweight","Birthweight","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. ","N","Limited baseline characteristics were recorded. ","Low","Low","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. \r\nLimited baseline characteristics were recorded. ",null,null,"Y","Y","The trial was open-label. ","PN","No deviations from the intended intervention were reported.","NA",null,"NA",null,"N","Methods did not specify if analysis was by intention to treat or per protocol. ","PN",null,"Some concerns","Some concerns","The trial was open-label. \r\nNo deviations from the intended intervention were reported.\r\n\r\n\r\nMethods did not specify if analysis was by intention to treat or per protocol. \r\n",null,null,"Y","One mother with a singleton pregnancy was lost to follow up before delivery.","NA",null,"NA",null,"NA",null,"Low","Low","One mother with a singleton pregnancy was lost to follow up before delivery.\r\n\r\n\r\n",null,null,"N",null,"PN",null,"PY","This was an open-label trail and blinding of outcome assessors was not described. ","PN","Outcome assessment not able to be influenced by knowledge of treatment allocation. ","NA",null,"Low","Low","\r\n\r\nThis was an open-label trail and blinding of outcome assessors was not described. \r\nOutcome assessment not able to be influenced by knowledge of treatment allocation. \r\n",null,null,"NI","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. ","N","No alternative definitions. ","PN",null,"Some concerns","Some concerns","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. \r\n\r\n",null,null,"Some concerns","Some concerns","Some concerns overall as there were some concerns of risk of bias for deviations from intended interventions because the trial was open label and some concerns of bias in selection of the reported result because of the limited detail of analysis methods and outcomes. "]
["2021/09/02 11.26","MAZ2008L3","AW&CM","Mazumder2008",2675250,"Betamethasone","Placebo","HC at birth","Birth OFC","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. ","N","Limited baseline characteristics were recorded. ","Low","Low","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. \r\nLimited baseline characteristics were recorded. ",null,null,"Y","Y","The trial was open-label. ","PN","No deviations from the intended intervention were reported.","NA",null,"NA",null,"N","Methods did not specify if analysis was by intention to treat or per protocol. ","PN",null,"Some concerns","Some concerns","The trial was open-label. \r\nNo deviations from the intended intervention were reported.\r\n\r\n\r\nMethods did not specify if analysis was by intention to treat or per protocol. \r\n",null,null,"Y","One mother with a singleton pregnancy was lost to follow up before delivery.","NA",null,"NA",null,"NA",null,"Low","Low","One mother with a singleton pregnancy was lost to follow up before delivery.\r\n\r\n\r\n",null,null,"N",null,"PN",null,"PY","This was an open-label trial and blinding of outcome assessors was not described. ","PN","Outcome assessment not able to be influenced by knowledge of treatment allocation. ","NA",null,"Low","Low","\r\n\r\nThis was an open-label trial and blinding of outcome assessors was not described. \r\nOutcome assessment not able to be influenced by knowledge of treatment allocation. \r\n",null,null,"NI","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. ","N",null,"PN",null,"Some concerns","Some concerns","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. \r\n\r\n",null,null,"Some concerns","Some concerns","Some concerns overall as there were some concerns of risk of bias for deviations from intended interventions because the trial was open label and some concerns of bias in selection of the reported result because of the limited detail of analysis methods and outcomes. "]
["2021/10/11 12.34","MAZ2008L4","AW&CM","Mazumder2008",2675250,"Betamethasone","Placebo","Length at birth","Length at birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. ","N","Limited baseline characteristics were recorded. ","Low","Low","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. \r\nLimited baseline characteristics were recorded. ",null,null,"Y","Y","The trial was open-label. ","PN","No deviations from the intended intervention were reported.","NA",null,"NA",null,"N","Methods did not specify if analysis was by intention to treat or per protocol. ","PN",null,"Some concerns","Some concerns","The trial was open-label. \r\nNo deviations from the intended intervention were reported.\r\n\r\n\r\nMethods did not specify if analysis was by intention to treat or per protocol. \r\n",null,null,"Y","One mother with a singleton pregnancy was lost to follow up before delivery.","NA",null,"NA",null,"NA",null,"Low","Low","One mother with a singleton pregnancy was lost to follow up before delivery.\r\n\r\n\r\n",null,null,"N",null,"PN",null,"PY","This was an open-label trial and blinding of outcome assessors was not described. ","PN","Outcome assessment not able to be influenced by knowledge of treatment allocation. ","NA",null,"Low","Low","\r\n\r\nThis was an open-label trial and blinding of outcome assessors was not described. \r\nOutcome assessment not able to be influenced by knowledge of treatment allocation. \r\n",null,null,"NI","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. ","N",null,"PN",null,"Some concerns","Some concerns","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. \r\n\r\n",null,null,"Some concerns","Some concerns","Some concerns overall as there were some concerns of risk of bias for deviations from intended interventions because the trial was open label and some concerns of bias in selection of the reported result because of the limited detail of analysis methods and outcomes. "]
["2022/01/12 09.06","MAZ2008L6","AW&CM","Mazumder2008",2675250,"Betamethasone","Placebo","Growth assessments at infant follow up","Growth assessments at 6months","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s)","Y","PY","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. ","N","Limited baseline characteristics were recorded. ","Low","Low","Simple randomisation used a website-generated random number list. Allocation slips were placed in opaque, sealed envelopes. \r\nLimited baseline characteristics were recorded. ",null,null,"Y","Y","The trial was open-label. ","PN","No deviations from the intended intervention were reported.","NA",null,"NA",null,"N","Methods did not specify if analysis was by intention to treat or per protocol. ","PN",null,"Some concerns","Some concerns","The trial was open-label. \r\nNo deviations from the intended intervention were reported.\r\n\r\n\r\nMethods did not specify if analysis was by intention to treat or per protocol. \r\n",null,null,"N","44/64 of those randomised and not known to be dead were assessed for this outcome (69%).","N","Sensitivity analysis not performed. ","PY",null,"PN",null,"Some concerns","Some concerns","44/64 of those randomised and not known to be dead were assessed for this outcome (69%).\r\nSensitivity analysis not performed. \r\n\r\n",null,null,"N",null,"PN",null,"PY","This was an open-label trial and blinding of outcome assessors was not described. ","PN",null,"NA",null,"Low","Low","\r\n\r\nThis was an open-label trial and blinding of outcome assessors was not described. \r\n\r\n",null,null,"NI","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. ","PN",null,"PN",null,"Some concerns","Some concerns","No SAP or trial registration available to review. Limited detail in analysis plans stated in methods. \r\n\r\n",null,null,"Some concerns","High","High risk overall as there were some concerns of risk of bias for deviations from intended interventions because the trial was open label, selection of the reported result because of the limited detail of analysis methods and outcomes, for measurement of the outcome as  blinding of outcome assessors was not described and missing outcome data as only 44/64(69%) of those randomised and not known to be dead were assessed for this outcome.\r\n\r\n\r\n"]
["2022/01/14 15.48","MUR2008A1","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","fetal or neonatal or infant death","Stillbirth plus neonatal death","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"Y","<1% loss to follow up","NA",null,"NA",null,"NA",null,"Low","Low","<1% loss to follow up",null,null,"N","Outcome is objective. ","N",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ","NA",null,"NA",null,"Low","Low","Outcome is objective. \r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","Although no SAP was available to review, those analyses that were not prespecified were noted in the methods making selection of this outcome definition and analysis based on results unlikely.","N","Outcome specified in trial registration document. ","N","Limited ways this outcome can be reported. ","Low","Low","Limited ways this outcome can be reported. Outcome specified in trial registration. Although no SAP or protocol was available to review, those analyses that were not prespecified were noted in the methods making selection of this outcome definition and analysis based on results unlikely.",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 15.48","MUR2008A6","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Severe RDS","Severe RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"Y","<1% loss to follow up","NA",null,"NA",null,"NA",null,"Low","Low","<1% loss to follow up\r\n\r\n\r\n",null,null,"N","Outcome based on radiographic evidence of RDS or need for surfactant therapy, with severity defined by requirement for invasive ventilation. ","PN",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Outcome based on radiographic evidence of RDS or need for surfactant therapy, with severity defined by requirement for invasive ventilation. \r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","Although SAP was not reviewed, those analyses that were not prespecified were noted in the methods making selection of this outcome definition and analysis based on results unlikely.","PN","Outcome specified but not defined in registration document but well defined in methods . ","PN",null,"Low","Low","Although SAP was not reviewed, those analyses that were not prespecified were noted in the methods making selection of this outcome definition and analysis based on results unlikely.\r\nOutcome specified but not defined in registration document but well defined in methods . \r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 15.49","MUR2008A7","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Severe lung disease","severe RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"Y","<1% loss to follow up","NA",null,"NA",null,"NA",null,"Low","Low","<1% loss to follow up\r\n\r\n\r\n",null,null,"N","Outcome based on radiographic evidence of RDS or need for surfactant therapy, with severity defined by requirement for invasive ventilation. ","PN",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Outcome based on radiographic evidence of RDS or need for surfactant therapy, with severity defined by requirement for invasive ventilation. \r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","Although SAP was not reviewed, those analyses that were not prespecified were noted in the methods making selection of this outcome definition and analysis based on results unlikely.","PN",null,"N",null,"Low","Low","Although SAP was not reviewed, those analyses that were not prespecified were noted in the methods making selection of this outcome definition and analysis based on results unlikely.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 15.53","MUR2008A8","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","chronic lung disease","BPD","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"Y","<1% loss to follow up","NA",null,"NA",null,"NA",null,"Low","Low","<1% loss to follow up",null,null,"N",null,"PN",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,"NA",null,"Low","Low","\r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   Outcome specified but not defined in trial registration but well defined in methods.","PN",null,"PN",null,"Low","Low","SAP and protocol were not available for review. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   Outcome specified but not defined in trial registration but well defined in methods.\r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 15.53","MUR2008A9","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","severe IVH","IVH grade 3 or 4 ","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"PY","The number with ultrasounds was unclear. Centres were encouraged to perform at least 2 cranial US for infants with BW <1500grams only. \r\n\r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low","The number with ultrasounds was unclear. Centres were encouraged to perform at least 2 cranial US for infants with BW <1500grams. Those without US are less likely to have the outcome of interest as they are likely to be >1500grams BW. \r\nThose without US may be less likely to have the outcome of interest as they are more likely to be >1500grams BW. \r\n",null,null,"N",null,"PN","Cranial US was routine if BW was <1500grams. ","N","Outcome assessors were blinded to allocation. ","NA",null,"NA",null,"Low","Low","\r\nCranial US was routine if BW was <1500grams. \r\nOutcome assessors were blinded to allocation. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","PN","Outcome used a standard definition of severe IVH. ","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\nOutcome used a standard definition of severe IVH. \r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 15.53","MUR2008A11","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","NEC","NEC","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"Y","<1% loss to follow up","NA",null,"NA",null,"NA",null,"Low","Low","<1% loss to follow up\r\n\r\n\r\n",null,null,"N",null,"PN",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","\r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely. Outcome specified in trial registration document. ","PN","Outcome clearly defined in methods. ","PN",null,"Low","Low","SAP and protocol were not available for review. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely. Outcome specified in trial registration document. \r\nOutcome clearly defined in methods. \r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 15.55","MUR2008A12","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Composite serious outcome ","\"composite primary outcome\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"PY","<1% loss to follow up","NA",null,"NA",null,"NA",null,"Low","Low","<1% loss to follow up\r\n\r\n\r\n",null,null,"N",null,"PN","Measurement of individual components was appropriate and due to blinded was unlikely to vary between groups. ","N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Measurement of individual components was appropriate and due to blinded was unlikely to vary between groups. Researchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely. Outcome specified in trial registration document. ","PN","registration record defined composite outcome. ","PN",null,"Low","Low","SAP and protocol were not available for review. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely. Outcome specified in trial registration document. \r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 15.56","MUR2008F1","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Gestational age at birth","mean GA at birth, >37 weeks, <37 weeks and <28 weeks reported","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"Y","<1% loss to follow up","NA",null,"NA",null,"NA",null,"Low","Low","<1% loss to follow up\r\n\r\n\r\n",null,null,"N","Method of measurement of gestation was not stated but likely used standard methods and was unlikely to differ between groups. ","N",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Method of measurement of gestation was not stated but likely used standard methods and was unlikely to differ between groups. \r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","N",null,"PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 16.11","MUR2008F2","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","SGA","BW <10th centile","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"PY","\"few participants are missing\"","NA",null,"NA",null,"NA",null,"Low","Low","Likely minimal losses: Authors report \"a few participants were missing for this outcome\"\r\n\r\n\r\n",null,null,"N","Weight measurement likely followed standard methods. ","PN",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Weight measurement likely followed standard methods. \r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","PN"," All expected measures were reported. Both BW <5th and <10th centile was reported. ","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\n All expected measures were reported. Both BW <5th and <10th centile was reported. \r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 16.11","MUR2008F3","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Admission to NICU","Admission to NICU","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"Y","<1% loss to follow up","NA",null,"NA",null,"NA",null,"Low","Low","<1% loss to follow up\r\n\r\n\r\n",null,null,"N","An objective outcome was used. ","PN",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","An objective outcome was used. \r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","N",null,"PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 16.11","MUR2008F4","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Proven infection whilst in NICU","\"neonatal infection\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"Y","<1% loss to follow up","NA",null,"NA",null,"NA",null,"Low","Low","<1% loss to follow up\r\n\r\n\r\n",null,null,"N","Infection was defined by clinical features and either microbiological or radiological evidence. ","PN",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Infection was defined by clinical features and either microbiological or radiological evidence. \r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","PN","Outcome clearly defined in methods. ","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\nOutcome clearly defined in methods. \r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 16.12","MUR2008F7","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","ROP","ROP","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"PN","773 in intervention and 821 in placebo group did not have an ophthalmologic assessment. ","N","No sensitivity analysis performed. ","PY",null,"PN",null,"Some concerns","Some concerns","773 in intervention and 821 in placebo group did not have an ophthalmologic assessment. \r\nNo sensitivity analysis performed. \r\n\r\n",null,null,"N",null,"PN","It is unclear how it was decided which infants had ophthalmologic assessments. ","N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","It is unclear how it was decided which infants had ophthalmologic assessments (likely local hospital protocols) but researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,"PY","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","PN",null,"PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\n\r\n",null,null,"Some concerns","Some concerns","Some concerns due to missing data: 773 in intervention and 821 in placebo group did not have an ophthalmologic assessment. "]
["2022/01/14 16.15","MUR2008F8","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","PVL","cystic PVL","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"PY","Centres were encouraged to perform at least 2 cranial US for infants with BW <1500grams only. ","NA",null,"NA",null,"NA",null,"Low","Low","Centres were encouraged to perform at least 2 cranial US for infants with BW <1500grams only. \r\n\r\n\r\n",null,null,"N",null,"PN","US routine if BW <1500g and encouraged to have 2 cranial US. ","N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up.","NA",null,"NA",null,"Low","Low","\r\nUS routine if BW <1500g and encouraged to have 2 cranial US. \r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up.\r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","PN","Outcome was clearly defined in methods and timeframe included in registration record. ","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 16.18","MUR2008F10","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","PDA","PDA needing treatment","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"Y","<1% loss to follow up","NA",null,"NA",null,"NA",null,"Low","Low","<1% loss to follow up\r\n\r\n\r\n",null,null,"N","Measured as PDA requiring treatment. ","PN",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Measured as PDA requiring treatment. \r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","PN",null,"PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 16.18","MUR2008F11","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Use of respiratory support (any)","\"any ventilatory support\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"Y","<1% loss to follow up","NA",null,"NA",null,"NA",null,"Low","Low","<1% loss to follow up",null,null,"N","Outcome based on care administered by the treating team, who were blinded to allocation. ","PN",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Outcome based on care administered by the treating team, who were blinded to allocation. \r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","N",null,"PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 16.18","MUR2008F12","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Use of invasive respiratory support ","Intubation and ventilation using ET tube","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"Y","<1% loss to follow up","NA",null,"NA",null,"NA",null,"Low","Low","<1% loss to follow up\r\n\r\n\r\n",null,null,"N","Outcome based on care administered by the treating team, who were blinded to allocation. ","PN",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Outcome based on care administered by the treating team, who were blinded to allocation. \r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","N",null,"PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 16.18","MUR2008F13","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Use of non-invasive respiratory support ","Other ventilatory support without intubation","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"Y","<1% loss to follow up","NA",null,"NA",null,"NA",null,"Low","Low","<1% loss to follow up\r\n\r\n\r\n",null,null,"N","Outcome based on care administered by the treating team, who were blinded to allocation. ","PN",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Outcome based on care administered by the treating team, who were blinded to allocation. \r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","N",null,"PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 16.18","MUR2008F14","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Use of oxygen supplementation","Use of oxygen supplementation","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"Y","<1% loss to follow up","NA",null,"NA",null,"NA",null,"Low","Low","<1% loss to follow up\r\n\r\n\r\n",null,null,"N","Outcome based on care administered by the treating team, who were blinded to allocation. ","PN",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Outcome based on care administered by the treating team, who were blinded to allocation. \r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","N",null,"PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 16.18","MUR2008F15","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Use of surfactant","Use of surfactant","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"Y","<1% loss to follow up","NA",null,"NA",null,"NA",null,"Low","Low","<1% loss to follow up\r\n\r\n\r\n",null,null,"N","Outcome based on care administered by the treating team, who were blinded to allocation. ","PN",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Outcome based on care administered by the treating team, who were blinded to allocation. \r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","N",null,"PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 16.19","MUR2008F17","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Use of postnatal corticosteroids","Use of postnatal corticosteroids","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"Y","<1% loss to follow up","NA",null,"NA",null,"NA",null,"Low","Low","<1% loss to follow up\r\n\r\n\r\n",null,null,"N","Outcome based on care administered by the treating team, who were blinded to allocation. ","PN",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Outcome based on care administered by the treating team, who were blinded to allocation. \r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","N",null,"PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 16.23","MUR2008F21","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Apgar score less than seven at five minutes","Apgar score less than seven at five minutes","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"Y","13 in intervention group and 14 in placebo group with unknown results. ","NA",null,"NA",null,"NA",null,"Low","Low","13 in intervention group and 14 in placebo group with unknown results. \r\n\r\n\r\n",null,null,"N","Apgar measurement is standardised. ","PN",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Apgar measurement is standardised. \r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","PN","This outcome was not in the registration document or methods but the cut-off of <7 at 5 minutes was the only one eligible for this analysis and is a standard cut-off. ","PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\nThis outcome was not in the registration document or methods but the cut-off of <7 at 5 minutes was the only one eligible for this analysis and is a standard cut-off. \r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 16.24","MUR2008L1","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Birthweight","Birthweight","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"Y","<1% loss to follow up","NA",null,"NA",null,"NA",null,"Low","Low","<1% loss to follow up\r\n\r\n\r\n",null,null,"PN","Measurement method not stated but likely standard.","N",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Measurement method not stated but likely standard.\r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","N",null,"PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 16.24","MUR2008L3","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","HC at birth","HC at birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"Y","<1% loss to follow up","NA",null,"NA",null,"NA",null,"Low","Low","<1% loss to follow up\r\n\r\n\r\n",null,null,"PN","Measurement method not stated but likely standard.","N",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Measurement method not stated but likely standard.\r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","N",null,"PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/14 16.24","MUR2008L4","AW&CC","Murphy2008",2675265,"Betamethasone","Placebo","Length at birth","Length at birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record); Conference abstract(s) about the trial","Y","Y","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. “All patients and caregivers were unaware of the treatment given”. ","N","Stratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ","Low","Low","A centrally controlled, computerised, telephone randomisation service was used. A similar-appearing placebo was used. \r\nStratification by centre and gestational age was used. No marked imbalance of baseline characteristics. ",null,null,"N","N","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. One woman in the repeat antenatal steroids group had allocation unmasked at the request of her physician but completed the trial. ","NA",null,"NA",null,"NA",null,"Y","Intention to treat analysis was used. ","NA",null,"Low","Low","The children’s families, clinicians and researchers associated with the trial remained unaware of assignment up to the 5 year follow up. Intention to treat analysis was used. \r\n",null,null,"Y","<1% loss to follow up","NA",null,"NA",null,"NA",null,"Low","Low","<1% loss to follow up\r\n\r\n\r\n",null,null,"PN","Measurement method not stated but likely standard.","N",null,"N","Researchers associated with the trial remained unaware of allocation up to 5 year follow up. ",null,null,null,null,"Low","Low","Measurement method not stated but likely standard.\r\n\r\nResearchers associated with the trial remained unaware of allocation up to 5 year follow up. \r\n\r\n",null,null,"PY","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   ","N",null,"PN",null,"Low","Low","SAP and protocol were not available for review. Outcome was not specified in trial registration. Those analyses that were not prespecified were noted in the methods, making selection of this outcome definition and analysis based on results unlikely.   \r\n\r\n",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/17 09.20","TEA1999A1","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","fetal, neonatal or infant death","death before infant discharge","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY",null,"NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not published as the trial was stopped early. \r\n",null,null,"Y","Missing data for 3/94 fetuses (3.2%) in each group. ","NA",null,"NA",null,"NA",null,"Low","Low","Missing data for 3/94 fetuses (3.2%) in each group. \r\n",null,null,"PN","Objective outcome. ","PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","Objective outcome. \r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished trial data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished trial data were included. \r\n\r\nOnly eligible data were selected and no analysis was reported by authors. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/13 09.49","TEA1999A5","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","RDS","RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY",null,"NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not performed as the trial was stopped early and not published. \r\n",null,null,"Y","Missing data for 4/94 (4%) in intervention and 7/94 in placebo group (7%).","NA",null,"NA",null,"NA",null,"Low","Low","Missing data for 4/94 (4%) in intervention and 7/94 in placebo group (7%).\r\n\r\n\r\n",null,null,"PN","Diagnosis by ultrasound. ","PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","Diagnosis by ultrasound. \r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/10 10.49","TEA1999A9","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","severe IVH","severe IVH","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY",null,"NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not performed as the trial was stopped early and not published. \r\n",null,null,"Y","Missing data for 8/94 (8.5%) in intervention and 7/94 (7.4%) in the placebo group. ","NA",null,"NA",null,"NA",null,"Low","Low","Missing data for 8/94 (8.5%) in intervention and 7/94 (7.4%) in the placebo group. \r\n\r\n\r\n",null,null,"PN",null,"PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","\r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/10 11.11","TEA1999A11","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","NEC","NEC","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY",null,"NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not performed as the trial was stopped early and not published. \r\n",null,null,"Y","Missing data for 5/94 (5%) in intervention and 7/94 (7%) in the placebo group. ","NA",null,"NA",null,"NA",null,"Low","Low","Missing data for 5/94 (5%) in intervention and 7/94 (7%) in the placebo group. \r\n\r\n",null,null,"PN",null,"PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","\r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/10 10.51","TEA1999A12","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","Composite serious outcome ","Composite serious outcome ","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY",null,"NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not performed as the trial was stopped early and not published. \r\n",null,null,"Y","Missing data for 3/94 fetuses (3.2%) in each group. ","NA",null,"NA",null,"NA",null,"Low","Low","Missing data for 3/94 fetuses (3.2%) in each group. \r\n\r\n\r\n",null,null,"PN",null,"PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","\r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/13 09.49","TEA1999F1","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","Gestational age at birth ",">37 weeks, <37 weeks, <28weeks, mean GA at birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY",null,"NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not performed as the trial was stopped early and not published. \r\n",null,null,"Y","Missing data for 3/94 fetuses (3.2%) in each group. ","NA",null,"NA",null,"NA",null,"Low","Low","Missing data for 3/94 fetuses (3.2%) in each group. \r\n\r\n\r\n",null,null,"PN","Gestational age likely measured using standard methods. ","PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","Gestational age likely measured using standard methods. \r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/13 09.53","TEA1999F4","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","Proven neonatal infection while in the NICU","Proven neonatal infection while in the NICU","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY",null,"NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not performed as the trial was stopped early and not published. \r\n",null,null,"PN","Missing data for 8/94 (8.5%) in intervention group and 16/94 (17%) in the placebo group. ","N",null,"PY","proportion with missing data differs between groups and similar to total number of events.","PN",null,"Some concerns","Some concerns","Proportion of missing data differs between groups. Missing data for 8/94 (8.5%) in intervention group and 16/94 (17%) in the placebo group. \r\n\r\n\r\n",null,null,"PN",null,"PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","\r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ",null,null,"Some concerns","Some concerns","Some concerns due to missing outcome data that differed between groups. "]
["2022/01/10 11.01","TEA1999F5","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","Early systemic neonatal infection ","Early systemic neonatal infection ","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY",null,"NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not performed as the trial was stopped early and not published. \r\n",null,null,"Y","Missing data for 8/94 (8.5%) in intervention and 13/94 (13.8%) in the placebo group. ","NA",null,"NA",null,"NA",null,"Low","Low","Missing data for 8/94 (8.5%) in intervention and 13/94 (13.8%) in the placebo group. \r\n\r\n\r\n",null,null,"PN",null,"PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","\r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/10 11.03","TEA1999F7","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","ROP","ROP","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY",null,"NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not performed as the trial was stopped early and not published. \r\n",null,null,"Y","Missing data for 5/94 (5%) in intervention and 7/94 (7%) in the placebo group","NA",null,"NA",null,"NA",null,"Low","Low","Missing data for 5/94 (5%) in intervention and 7/94 (7%) in the placebo group\r\n\r\n\r\n",null,null,"PN",null,"PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","\r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/10 11.03","TEA1999F8","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","PVL","PVL","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY",null,"NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not performed as the trial was stopped early and not published. \r\n",null,null,"Y","Missing data for 5/94 (5%) in intervention and 7/94 (7%) in the placebo group","NA",null,"NA",null,"NA",null,"Low","Low","Missing data for 5/94 (5%) in intervention and 7/94 (7%) in the placebo group\r\n\r\n",null,null,"PN",null,"PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","\r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/10 11.04","TEA1999F10","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","PDA","PDA","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY",null,"NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not performed as the trial was stopped early and not published. \r\n",null,null,"Y","Missing data for 5/94 (5%) in intervention and 7/94 (7%) in the placebo group","NA",null,"NA",null,"NA",null,"Low","Low","Missing data for 5/94 (5%) in intervention and 7/94 (7%) in the placebo group\r\n\r\n\r\n",null,null,"PN",null,"PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","\r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/13 09.58","TEA1999F11","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","Use of respiratory support ","Use of respiratory support ","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY",null,"NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not performed as the trial was stopped early and not published. \r\n",null,null,"Y","Missing data for 4/94 (4%) in intervention and 7/94 (7%) in the placebo group. ","NA",null,"NA",null,"NA",null,"Low","Low","Missing data for 4/94 (4%) in intervention and 7/94 (7%) in the placebo group. \r\n\r\n\r\n",null,null,"PN","Outcome based on care administered by the treating team, who were likely blinded to allocation.  Limited information but based on registration document and trial centre likely assessors were blinded. ","PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","Outcome based on care administered by the treating team, who were likely blinded to allocation.  Limited information but based on registration document and trial centre likely assessors were blinded. \r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/13 09.58","TEA1999F14","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","Use of oxygen supplementation","Use of oxygen supplementation","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY",null,"NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not performed as the trial was stopped early and not published. \r\n",null,null,"Y","Missing data for 4/94 (4%) in intervention and 7/94 (7%) in the placebo group. ","NA",null,"NA",null,"NA",null,"Low","Low","Missing data for 4/94 (4%) in intervention and 7/94 (7%) in the placebo group. \r\n\r\n\r\n",null,null,"PN","Outcome based on care administered by the treating team, who were likely blinded to allocation.  Limited information but based on registration document and trial centre likely assessors were blinded. ","PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","Outcome based on care administered by the treating team, who were likely blinded to allocation.  Limited information but based on registration document and trial centre likely assessors were blinded. \r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/13 09.58","TEA1999F15","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","Use of surfactant","Use of surfactant","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY",null,"NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not performed as the trial was stopped early and not published. \r\n",null,null,"Y","Missing data for 4/94 (4%) in intervention and 7/94 (7%) in the placebo group. ","NA",null,"NA",null,"NA",null,"Low","Low","Missing data for 4/94 (4%) in intervention and 7/94 (7%) in the placebo group. \r\n\r\n\r\n",null,null,"PN","Outcome based on care administered by the treating team, who were likely blinded to allocation.  Limited information but based on registration document and trial centre likely assessors were blinded. ","PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","Outcome based on care administered by the treating team, who were likely blinded to allocation.  Limited information but based on registration document and trial centre likely assessors were blinded. \r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/13 09.58","TEA1999F17","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","Use of postnatal corticosteroids","Use of postnatal corticosteroids","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY",null,"NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not performed as the trial was stopped early and not published. \r\n",null,null,"Y","Missing data for 5/94 (5%) in intervention and 7/94 (7%) in the placebo group. ","NA",null,"NA",null,"NA",null,"Low","Low","Missing data for 5/94 (5%) in intervention and 7/94 (7%) in the placebo group. \r\n\r\n\r\n",null,null,"PN","Outcome based on care administered by the treating team, who were likely blinded to allocation.  Limited information but based on registration document and trial centre likely assessors were blinded. ","PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","Outcome based on care administered by the treating team, who were likely blinded to allocation.  Limited information but based on registration document and trial centre likely assessors were blinded. \r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/10 11.09","TEA1999F18","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","Air leak syndrome","Air leak syndrome","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY",null,"NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not performed as the trial was stopped early and not published. \r\n",null,null,"Y","Missing data for 5/94 (5.3%) in intervention and 8/94 (8.5%) in the placebo group. ","NA",null,"NA",null,"NA",null,"Low","Low","Missing data for 5/94 (5.3%) in intervention and 8/94 (8.5%) in the placebo group. \r\n\r\n\r\n",null,null,"PN",null,"PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","\r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2022/01/10 11.11","TEA1999L1","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","BW","BW mean and SD calculated using SE","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY",null,"NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not performed as the trial was stopped early and not published. \r\n",null,null,"Y","Missing data for 3/94 fetuses (3.2%) in each group. ","NA",null,"NA",null,"NA",null,"Low","Low","Missing data for 3/94 fetuses (3.2%) in each group. \r\n\r\n\r\n",null,null,"PN",null,"PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","\r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ",null,null,"Low","Low","Low risk of bias for all domains. "]
["2021/10/12 09.25","TEA1999L3","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","HC at birth","HC at birth mean and SD calculated using SE","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY",null,"NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not performed as the trial was stopped early and not published. \r\n",null,null,"N","Data available for fewer than 50% of those randomised. ","N",null,"PY",null,"PY",null,"High","High","Data available for fewer than 50% of those randomised. \r\n\r\n\r\n",null,null,"PN",null,"PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","\r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ",null,null,"High","High","High risk as data available for <50% randomised. "]
["2022/01/13 10.10","TEA1999L14","AW&JH","TEAMS1999",2675328,"Betamethasone","Placebo","HPA axis function","HPA axis suppression","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Non-commercial trial registry record (e.g. ClinicalTrials.gov record); “Grey literature” (e.g. unpublished thesis)","PY","PY",null,"NI","Baseline information not available in detail. ","Low","Low","Baseline information not available in detail. Limited information but based on registration document and trial centre standard protocols this was likely performed with random sequence generation and allocation concealment. ",null,null,"PN","PN","Limited information but based on registration document and trial centre likely participants were blinded.","NA",null,"NA",null,"NA",null,"PY","No analysis was published as the trial was stopped early. ","NA",null,"Low","Low","Limited information but based on registration document and trial centre likely participants were blinded.\r\n\r\n\r\n\r\nAnalysis was not performed as the trial was stopped early and not published. \r\n",null,null,"Y","Missing data for 5/94 (5%) in intervention and 7/94 (7%) in the placebo group. ","NA",null,"NA",null,"NA",null,"Low","Low","Missing data for 5/94 (5%) in intervention and 7/94 (7%) in the placebo group. \r\n\r\n\r\n",null,null,"PN",null,"PN",null,"PN","Limited information but based on registration document and trial centre likely assessors were blinded.","NA",null,"NA",null,"Low","Low","\r\n\r\nLimited information but based on registration document and trial centre likely assessors were blinded.\r\n\r\n",null,null,"Y","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ","N",null,"N","Only eligible data were selected and no analysis was reported by authors. ","Low","Low","No analyses were published by author as trial stopped early. Unpublished IPD data were included. ",null,null,"Low","Low","Low risk of bias for all domains. "]

{"sheet":"Summary","index":2,"n_rows":242,"n_cols":27,"rows_kept":242,"cut":false,"hidden":false,"merged":[]}
["Unique ID","Reviewer","Study ID","Reference","Experimental","Comparator","Outcome","Result","Aim","Effect of adhering to intervention?","Weight","Randomization process","Deviations from intended interventions","Mising outcome data","Measurement of the outcome","Selection of the reported result","Overall Bias",null,null,null,null,"Randomization process","Deviations from intended interventions","Mising outcome data","Measurement of the outcome","Selection of the reported result","Overall Bias"]
["AGH2002A1","AW","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Fetal, neonatal or infant death","Fetal, neonatal or infant death","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low",null,null,null,"Assignment to intervention (the 'intention-to-treat' effect)"]
["AGH2002A2","AW","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Fetal death","Fetal death","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low",null,null,null,"Total number of study = 241"]
["AGH2002A3","AW","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Neonatal Death","Neonatal Death","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low",null,null,null,"Low risk",92.1,83.8,92.1,83.4,83.8,63.5]
["AGH2002A5","AW","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Respiratory distress syndrome","Respiratory distress syndrome","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low",null,null,null,"Some concerns",7.9,7.9,5,14.9,15.4,20.7]
["AGH2002A8","AW","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Chronic lung disease","Chronic lung disease","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low",null,null,null,"High risk",0,8.3000000000000007,2.9,1.2,0.4,13.3]
["AGH2002A9","AW","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Severe IVH","Severe IVH","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","High","High",null,null,null,"Adhering to intervention (the 'per-protocol' effect)"]
["AGH2002A11","AW","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Necrotising enterocolitis","Necrotising enterocolitis","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low",null,null,null,"Total number of study = 0"]
["AGH2002A12","AW","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Composite serious outcome","Composite serious outcome","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","High",null,null,null,"Low risk"]
["AGH2002F1","AW","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Gestational age at birth","Gestational age at birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low",null,null,null,"Some concerns"]
["AGH2002F2","AW","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","SGA","<10th centile","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Some concerns","Some concerns",null,null,null,"High risk"]
["AGH2002F4","AW","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Proven neonatal infection in NICU","Proven neonatal infection in NICU","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Some concerns"]
["AGH2002F7","AW","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Retinopathy of prematurity","Retinopathy of prematurity","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","High"]
["AGH2002F8","AW","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Periventricular leucomalacia","Periventricular leucomalacia","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","High"]
["AGH2002F10","AW","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Patent ductus arteriosus","Patent ductus arteriosus (indomethacin treated)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Some concerns","Some concerns"]
["AGH2002L1","AW","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Birthweight","Birthweight","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["AGH2002L2","AW","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Interval between trial entry and birth","Interval between trial entry and birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["AGH2002L3","AW","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Head circumference at birth","Head circumference at birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["AGH2002L4","AW","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Length at birth","Length at birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["AGH2002L14","AW","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Infant measures of HPA axis function","Infant measures of HPA axis function","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","High","Low","Low","High"]
["AGH2002Q3","AW","Aghajafari2002",2675224,"Repeat betamethasone","Placebo","Length of stay in NICU","Length of stay in NICU","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Some concerns"]
["GAR2009A2","AW","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Fetal death","Perinatal death","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["GAR2009A3","AW","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Neonatal death","Neonatal death","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["GAR2009A5","AW","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Respiratory distress syndrome ","RDS in whole group","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["GAR2009A8","AW","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Chronic Lung disease","Bronchopulmonary dyslpasia","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["GAR2009A9","AW","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Severe IVH","Severe IVH","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Some concerns","Some concerns","Low","Some concerns"]
["GAR2009A10","AW","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","IVH","IVH","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Some concerns","Low","Some concerns"]
["GAR2009A11","AW","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Necrotizing enterocolitis","Necrotizing enterocolitis","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","High","Low","Low","High"]
["GAR2009A12","AW","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Composite serious outcome ","Composite neonatal morbidity","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Some concerns","Low","Low"]
["GAR2009F1III","AW","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Gestational age at birth","Gestational age at birth <34 weeks","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["GAR2009F1V","AW","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","gestational age at birth","mean gestational age at birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["GAR2009F2","AW","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Small for gestational age","\"IUGR\" defined as <10th centile for weight at birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["GAR2009F4","AW","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Proven neonatal infection in NICU","Blood culture proven sepsis","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","High","Low","Low","High"]
["GAR2009F7","AW","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Retinopathy of prematurity","Retinopathy of prematurity","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Some concerns","Some concerns","Some concerns","High"]
["GAR2009F8","AW","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Periventricular leucomalacia","Periventricular leucomalacia","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Some concerns","Low","Some concerns"]
["GAR2009F15","AW","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Use fo surfactant","Use of surfactant","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["GAR2009F18","AW","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Air leak syndrome","pneumothorax","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Some concerns","Low","Low","Some concerns"]
["GAR2009F21","AW","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Apgar score less than seven at five minutes","Apgar score less than seven at five minutes","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["GAR2009L1","AW","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Birthweight","Mean birthweight","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["GAR2009L2","AW","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Interval between trial entry and birth","Interval between trial entry and birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["GAR2009L3","AW","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Head circumference at birth","Head circumference at birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["GAR2009F11","AW","Garite2009",2675239,"Repeat antenatal steroid (betamethasone or dexamethasone)","Placebo","Use of respiratory support ","\"ventilator\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006A2","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Fetal death","Stillbirth","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006A3","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Neonatal death","death before initial discharge home. ","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006A5","AW","Crowther 2006",2675226,"Betamethasone","Placebo","RDS","RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006A7","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Severe lung disease","severe lung disease","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006A8","AW","Crowther 2006",2675226,"Betamethasone","Placebo","chronic lung disease","Oxygen requirement at 36weeks post conception","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006A9","AW","Crowther 2006",2675226,"Betamethasone","Placebo","severe IVH","Grade 3 or 4 IVH, RR 0.64","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006A10","AW","Crowther 2006",2675226,"Betamethasone","Placebo","IVH","IVH RR 0.86 in original trial publication. ","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006A11","AW","Crowther 2006",2675226,"Betamethasone","Placebo","NEC","RR 0.47, \"Proven necrotizing enterocolitis\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006A12","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Composite serious outcome","RR 0.79, \"Other serious neonatal morbidity\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Some concerns","Some concerns"]
["CRO2006F1","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Gestational age at birth","mean gestational age at birth, >37 weeks, <37 weeks, <34 weeks, <28 weeks","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006F3","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Admission to NICU","Admission to NICU, RR 1.05","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006F4","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Proven neonatal infection while in NICU","\"Any proven infection\", RR 0.98","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006F5","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Early systemic neonatal infection(<48 hours after birth)","\"systemic infection suspected <48hours after birth), RR 1.00","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006F7","AW","Crowther 2006",2675226,"Betamethasone","Placebo","ROP","ROP, RR 0.94","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006F8","AW","Crowther 2006",2675226,"Betamethasone","Placebo","PVL","PVL, RR 0.53","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006F10","AW","Crowther 2006",2675226,"Betamethasone","Placebo","PDA","PDA, RR 0.59","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006F12","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Use of invasive respiratory support","\"use of mechanical ventilation\", RR 0.87","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006F13","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Use of non invasive respiratory support","\"use of oxygen therapy\", RR 0.90","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006F14","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Use of oxygen supplementation","\"use of oxygen therapy\", RR 0.90","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006F15","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Use of surfactant","Use of surfactant, rr 0.81","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006F16","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Use of nitric oxide for respiratory support","Use of nitric oxide for respiratory support, rr  0.60","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006F17","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Use of postnatal corticosteroids","\"use of steroids postnatally\", rr 1.39","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006F18","AW","Crowther 2006",2675226,"Betamethasone","Placebo","air leak syndrome","air leak syndrome, rr 1.1","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006F20","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Use of inotropic support","Use of inotropic support, rr 0.75","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006F21","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Apgar score <7 at 5 minutes","Apgar score <7 at 5 minutes, rr 0.92","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006F22","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Cardiac hypertrophy ","thickness of IVS or LVPW in mm. ","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006L1","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Birthweight","birthweight, z scores","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006L3","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Head circumference at birth","Head circumference at birth and z scores","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006L4","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Length at birth ","Length at birth and z scores","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006L5I","AW","Crowther 2006",2675226,"Betamethasone","Placebo","weight at primary hopsital discharge","weight at discharge, z scores","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006L5II","AW","Crowther 2006",2675226,"Betamethasone","Placebo","head cicrumference  at primary hospital discharge","HC at discharge, z scores ","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006L5III","AW","Crowther 2006",2675226,"Betamethasone","Placebo","length at primary hospital discharge","length at discharge, z scores","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006L8","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Duration or invasive respiratory support","calculated mean and SD for duration of mechanical ventilation","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006L9","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Duration of non-invasive respiratory support","calculated mean and SD from \"duration of oxygen therapy\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","\r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n","Prespecified analysis plan noted in methods but without a timestamp. \r\nTimepoint of assessment stated. \r\nReporting measure consistent for outcomes based on durations measured in days. ","Random-number sequence generated by computer with variable block sizes and stratification by centre, gestational age and number of fetuses.\r\nAllocation was performed centrally and masked treatment packs were provided. \r\n\r\n\r\nTreatment packs appeared identical with opaque syringes. Women and perinatal staff were masked to allocation. \r\n\r\n\r\n\r\nAnalysis was by intention to treat. \r\n\r\n\r\nOutcome assessors were blinded to allocation. \r\n\r\n\r\nPrespecified analysis plan noted in methods but without a timestamp. \r\nTimepoint of assessment stated. \r\nReporting measure consistent for outcomes based on durations measured in days. "]
["CRO2006L10","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Duration of oxygen supplmentation","calculated mean and SD from \"duration of oxygen therapy\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006L14I","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Measures of HPA axis function","Birth cord serum cortisol, Women at the Women’s and Children’s Hospital, Adelaide","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Some concerns","Low","Low","Some concerns"]
["CRO2006L14II","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Measures of HPA axis function","Day 3,7,14,21 basal salivary cortisol, Babies at Women’s and Children’s Hospital, Adelaide","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Some concerns","Low","Low","Some concerns"]
["CRO2006L14III","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Measures of HPA axis function","Post stress day 3 salivary cortisol, Babies at Women’s and Children’s Hospital, Adelaide","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Some concerns","Low","Low","Some concerns"]
["CRO2006L14IV","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Measures of HPA axis function","ACTH, Cortisol at baseline day 2-3 ","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006L14V","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Measures of HPA axis function","Post metyrapone ACTH, 11 deoxycortisol and cortisol","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["CRO2006Q4","AW","Crowther 2006",2675226,"Betamethasone","Placebo","Length on infant hospitalisation ","\"length of hospital stay\", p value 0.66","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MCE2002F1","AW","McEvoy 2002",2675252,"Betamethasone","Placebo","Mean gestational age at birth","Birth weight mean and SD (in grams)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MCE2002F15","AW","McEvoy 2002",2675252,"Betamethasone","Placebo","Use of surfactant","\"surfactant administration \"","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MCE2002L1","AW","McEvoy 2002",2675252,"Betamethasone","Placebo","Birthweight","Birthweight mean and SD","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MCE2002L3","AW","McEvoy 2002",2675252,"Betamethasone","Placebo","Head circumference at birth","\"Admission head circumference\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MCE2002L8","AW","McEvoy 2002",2675252,"Betamethasone","Placebo","Duration of invasive respiratory support","days on IMV","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MCE2002L9","AW","McEvoy 2002",2675252,"Betamethasone","Placebo","Duration of non-invasive respiratory support","days on oxygen","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MCE2002L10","AW","McEvoy 2002",2675252,"Betamethasone","Placebo","Duration of oxygen supplementation","days on oxygen","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MCE2002L14","AW","McEvoy 2002",2675252,"Betamethasone","Placebo","Measures of HPA axis function","Basal cortisol and post ACTH stimulation cortisol\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","High","Low","Low","High"]
["GUI2002A2","AW","Guinn 2002",2675243,"Betamethasone","Placebo","Fetal death","\"stillborn\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["GUI2002A3","AW","Guinn 2002",2675243,"Betamethasone","Placebo","Neonatal death","\"perinatal death\" minus fetal death","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["GUI2002A5","AW","Guinn 2002",2675243,"Betamethasone","Placebo","Respiratory distress syndrome(RDS) (however defined by authors)","RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Some concerns","Low","Some concerns"]
["GUI2002A6","AW","Guinn 2002",2675243,"Betamethasone","Placebo","Severe RDS (however defined by authors",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Some concerns","Low","Some concerns"]
["GUI2002A7","AW","Guinn 2002",2675243,"Betamethasone","Placebo","Severe lung disease (however defined by authors)",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Some concerns","Low","Some concerns"]
["GUI2002A8","AW","Guinn 2002",2675243,"Betamethasone","Placebo","Chronic lung disease (however defined by authors)",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Some concerns","Low","Some concerns"]
["GUI2002A9","AW","Guinn 2002",2675243,"Betamethasone","Placebo","Severe IVH (grade 3 and 4)",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Some concerns"]
["GUI2002A10","AW","Guinn 2002",2675243,"Betamethasone","Placebo","Intraventricular haemorrhage (IVH).",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Some concerns"]
["GUI2002A11","AW","Guinn 2002",2675243,"Betamethasone","Placebo","Necrotising enterocolitis (however defined by authors)",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Some concerns"]
["GUI2002A12","AW","Guinn 2002",2675243,"Betamethasone","Placebo","Composite serious outcome (however defined by authors)",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Some concerns"]
["GUI2002F1","AW","Guinn 2002",2675243,"Betamethasone","Placebo","very preterm birth less than 34 weeks",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["GUI2002F4","AW","Guinn 2002",2675243,"Betamethasone","Placebo","Proven neonatal infection while in the NICU","\"Proven sepsis\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Some concerns"]
["GUI2002F8","AW","Guinn 2002",2675243,"Betamethasone","Placebo","Periventricular leucomalacia (however defined by authors)","\"isolated PVL\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","High"]
["GUI2002F15","AW","Guinn 2002",2675243,"Betamethasone","Placebo","Use of surfactant","\"received one or more course of surfactant\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["GUI2002F17","AW","Guinn 2002",2675243,"Betamethasone","Placebo","Use of postnatal corticosteroids","\"postnatal steroids for BPD\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["GUI2002L1","AW","Guinn 2002",2675243,"Betamethasone","Placebo","Birthweight","Birthweight","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["GUI2002L2","AW","Guinn 2002",2675243,"Betamethasone","Placebo","Interval between trial entry and birth","\"latency interval\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["GUI2002L3","AW","Guinn 2002",2675243,"Betamethasone","Placebo","Head circumference at birth","\"head circumference\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["GUI2002Q4","AW","Guinn 2002",2675243,"Betamethasone","Placebo","Length of infant hospitalisation ","\"neonatal hospital stay\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007A2","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","Fetal death","\"fetus mortus\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007A3","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","Neonatal death","Death during first hospitalisation","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007A5","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","RDS","RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007A6","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","Severe RDS (however defined by authors","Severe RDS (however defined by authors","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007A7","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","Severe lung disease","Severe RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007A8","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","Chronic lung disease","BPD","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007A9","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","severe IVH","IVH grade 3 or 4 ","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007A10","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","IVH","IVH, any grade","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Some concerns","Low","Low"]
["PEL2007A11","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","NEC","NEC","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007A12","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","composite serious outcome","death or RDS or severe IVH","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007F1","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","Gestational age at birth","mean GA at birth, extremely preterm birth <28weeks, very preterm birth <34 weeks. ","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007F2","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","SGA","SGA","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007F4","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","infection whilst in NICU","early + late systemic infection","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007F5","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","Early systemic neonatal infection","Sepsis age <3days","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007F6","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","Late systemic neonatal infection","Sepsis ≥ 3 days after birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007F7","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","ROP","ROP, any grade","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007F8","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","PVL","cystic periventricular leucomalacia","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007F10","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","PDA","PDA","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007F12","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","Use of invasive respiratory support ","mechanical ventilation","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007F13","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","Use of non-invasive respiratory support ","nasal CPAP","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007F15","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","Use of surfactant","Use of surfactant","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007F20","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","Use of inotropic support","\"inotropes\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007L1","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","Birthweight","Birthweight","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007L2","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","Interval between trial entry and birth","Time from intervention to birth, mean and SD calculated from median and IQR","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007L3","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","Head circumference at birth","HC","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007L4","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","Length at birth ","Length","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007L8","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","Duration of invasive respiratory support ","Duration of mechanical ventilation, mean and SD calculated from median and IQR","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007L9","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","Duration of non-invasive respiratory support ","Duration of nasal CPAP, calculated mean and SD from Median and IQR","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["PEL2007L10","AW","Peltoniemi2007",2675274,"Betamethasone","Placebo","Duration of oxygen supplementation","Calculated mean and SD from median and IQR","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["WAP2006A5","AW","Wapner2006",2675283,"Betamethasone","Placebo","RDS","RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["WAP2006A6","AW","Wapner2006",2675283,"Betamethasone","Placebo","Severe RDS (however defined by authors","Severe RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["WAP2006A7","AW","Wapner2006",2675283,"Betamethasone","Placebo","Severe lung disease","severe RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["WAP2006A8","AW","Wapner2006",2675283,"Betamethasone","Placebo","Chronic lung disease","chronic lung disease","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["WAP2006A10","AW","Wapner2006",2675283,"Betamethasone","Placebo","IVH","IVH","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["WAP2006A11","AW","Wapner2006",2675283,"Betamethasone","Placebo","NEC","NEC","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["WAP2006A12","AW","Wapner2006",2675283,"Betamethasone","Placebo","composite serious outcome","composite neonatal neonatal morbidity","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["WAP2006F1","AW","Wapner2006",2675283,"Betamethasone","Placebo","gestational age at birth ","term birth, preterm birth, mean GA at birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["WAP2006F2","AW","Wapner2006",2675283,"Betamethasone","Placebo","SGA","BW <5th centile","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["WAP2006F4","AW","Wapner2006",2675283,"Betamethasone","Placebo","Proven neonatal infection while in the NICU","\"sepsis\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Some concerns","Some concerns"]
["WAP2006F7","AW","Wapner2006",2675283,"Betamethasone","Placebo","ROP","ROP","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["WAP2006F10","AW","Wapner2006",2675283,"Betamethasone","Placebo","PDA","PDA","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Some concerns","Some concerns"]
["WAP2006F11","AW","Wapner2006",2675283,"Betamethasone","Placebo","Use of respiratory support  ","highest of ventilator or any CPAP","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["WAP2006F12","AW","Wapner2006",2675283,"Betamethasone","Placebo","Use of invasive respiratory support ","on ventilator support","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["WAP2006F13","AW","Wapner2006",2675283,"Betamethasone","Placebo","Use of non-invasive respiratory support ","any CPAP","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["WAP2006F15","AW","Wapner2006",2675283,"Betamethasone","Placebo","use of surfactant","use of surfactant","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["WAP2006F18","AW","Wapner2006",2675283,"Betamethasone","Placebo","Air leak syndrome","pneumothorax","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["WAP2006L1","AW","Wapner2006",2675283,"Betamethasone","Placebo","Birthweight","Birthweight and multiples of the median","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["WAP2006L2","AW","Wapner2006",2675283,"Betamethasone","Placebo","Interval between trial entry and birth","latency from randomisation to delivery","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["WAP2006L3","AW","Wapner2006",2675283,"Betamethasone","Placebo","HC at birth","HC at birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["WAP2006L4","AW","Wapner2006",2675283,"Betamethasone","Placebo","length at birth","length at birth and multiples of the median","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["WAP2006L14","AW","Wapner2006",2675283,"Betamethasone","Placebo","measures of HPA axis function","cord cortisol concentration","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Some concerns","Low","Some concerns","Some concerns"]
["McE2010A2","AW","McEvoy2010",2675256,"Betamethasone","Placebo","fetal death","fetal death","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["McE2010A3","AW","McEvoy2010",2675256,"Betamethasone","Placebo","neonatal death","neonatal death","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["McE2010A5","AW","McEvoy2010",2675256,"Betamethasone","Placebo","RDS","RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["McE2010A8","AW","McEvoy2010",2675256,"Betamethasone","Placebo","Chronic lung disease","Chronic lung disease","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Some concerns","Some concerns","Some concerns"]
["McE2010F1","AW","McEvoy2010",2675256,"Betamethasone","Placebo","GA at birth","Mean GA at birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low"]
["McE2010F2","AW","McEvoy2010",2675256,"Betamethasone","Placebo","SGA","SGA","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Some concerns","Some concerns"]
["McE2010F12","AW","McEvoy2010",2675256,"Betamethasone","Placebo","Use of invasive respiratory support ","mechanical ventilation","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low"]
["McE2010L1","AW","McEvoy2010",2675256,"Betamethasone","Placebo","Birthweight","Birthweight","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["McE2010L2","AW","McEvoy2010",2675256,"Betamethasone","Placebo","Interval between trial entry and birth","mean and SD Interval between trial entry and birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["McE2010L3","AW","McEvoy2010",2675256,"Betamethasone","Placebo","Head circumference at birth ","Head circumference at birth ","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low"]
["McE2010L4","AW","McEvoy2010",2675256,"Betamethasone","Placebo","Length at birth ","Length at birth ","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["McE2010L5","AW","McEvoy2010",2675256,"Betamethasone","Placebo","Growth assessments at primary hospital discharge","Growth assessments at primary hospital discharge","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Some concerns","Low","Low","Some concerns"]
["McE2010L6","AW","McEvoy2010",2675256,"Betamethasone","Placebo","Growth assessments at infant follow-up ","Growth assessments at infant follow-up 1-2years","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","High","Low","Low","High"]
["McE2010L8","AW","McEvoy2010",2675256,"Betamethasone","Placebo","Duration of invasive respiratory support","Duration of mechanical ventilation, mean and SD calculated from median and IQR","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["McE2010L10","AW","McEvoy2010",2675256,"Betamethasone","Placebo","Duration of oxygen supplementation ","Duration of oxygen supplementation, calculated mean and SD","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["McE2010Q4","AW","McEvoy2010",2675256,"Betamethasone","Placebo","Length of infant hospitalisation ","Length of infant hospitalisation, calculated mean and SD","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low"]
["MAZ2008A2","AW","Mazumder2008",2675250,"Betamethasone","Placebo","fetal death","fetal death","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Low","Low","Low","High"]
["MAZ2008A3","AW","Mazumder2008",2675250,"Betamethasone","Placebo","neonatal death","neonatal death","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Low","Low","Low","High"]
["MAZ2008A5","AW","Mazumder2008",2675250,"Betamethasone","Placebo","RDS","RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Low","Some concerns","Low","High"]
["MAZ2008A6","AW","Mazumder2008",2675250,"Betamethasone","Placebo","Severe RDS","Severe RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Low","Some concerns","Low","High"]
["MAZ2008A7","AW","Mazumder2008",2675250,"Betamethasone","Placebo","Severe lung disease","Severe RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Low","Some concerns","Low","High"]
["MAZ2008A8","AW","Mazumder2008",2675250,"Betamethasone","Placebo","chronic lung disease","BPD","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Low","High","Some concerns","High"]
["MAZ2008A10","AW","Mazumder2008",2675250,"Betamethasone","Placebo","IVH","IVH","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Low","Some concerns","Low","High"]
["MAZ2008A11","AW","Mazumder2008",2675250,"Betamethasone","Placebo","NEC","NEC","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Low","High","Low","High"]
["MAZ2008F2","AW","Mazumder2008",2675250,"Betamethasone","Placebo","SGA","SGA","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Low","Low","Some concerns","High"]
["MAZ2008F4","AW","Mazumder2008",2675250,"Betamethasone","Placebo","Proven neonatal infection while in the NICU","early onset sepsis+late onset sepsis","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Low","Some concerns","Low","High"]
["MAZ2008F5","AW","Mazumder2008",2675250,"Betamethasone","Placebo","Early systemic neonatal infection ","\"early onset sepsis\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Low","Some concerns","Low","High"]
["MAZ2008F6","AW","Mazumder2008",2675250,"Betamethasone","Placebo","Late systemic neonatal infection ","\"late onsent sepsis\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Low","Some concerns","Low","High"]
["MAZ2008F7","AW","Mazumder2008",2675250,"Betamethasone","Placebo","ROP","ROP","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Low","Some concerns","Some concerns","High"]
["MAZ2008F8","AW","Mazumder2008",2675250,"Betamethasone","Placebo","PVL","PVL","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Low","Some concerns","Some concerns","High"]
["MAZ2008F9","AW","Mazumder2008",2675250,"Betamethasone","Placebo","neonatal encephalopathy","neonatal encephalopathy","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Low","High","Some concerns","High"]
["MAZ2008F10","AW","Mazumder2008",2675250,"Betamethasone","Placebo","PDA","PDA","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Low","Some concerns","Some concerns","High"]
["MAZ2008F11","AW","Mazumder2008",2675250,"Betamethasone","Placebo","Use of surfactant","Use of surfactant","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Low","Low","Low","High"]
["MAZ2008L1","AW","Mazumder2008",2675250,"Betamethasone","Placebo","Birthweight","Birthweight","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Low","Low","Low","High"]
["MAZ2008FL3","AW","Mazumder2008",2675250,"Betamethasone","Placebo","HC at birth","Birth OFC","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Low","Low","Low","High"]
["MAZ2008FL4","AW","Mazumder2008",2675250,"Betamethasone","Placebo","Growth assessments at infant follow up","Growth assessments at 6months","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Some concerns","Low","Low","High"]
["MUR2008A2","AW","Murphy2008",2675265,"Betamethasone","Placebo","Fetal death","Stillbirth","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MUR2008A3","AW","Murphy2008",2675265,"Betamethasone","Placebo","Neonatal death","Neonatal death <28days","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MUR2008A6","AW","Murphy2008",2675265,"Betamethasone","Placebo","Severe RDS","Severe RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MUR2008A7","AW","Murphy2008",2675265,"Betamethasone","Placebo","Severe lung disease","severe RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MUR2008A8","AW","Murphy2008",2675265,"Betamethasone","Placebo","chronic lung disease","BPD","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MUR2008A9","AW","Murphy2008",2675265,"Betamethasone","Placebo","severe IVH","IVH grade 3 or 4 ","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Some concerns","Some concerns","Low","Some concerns"]
["MUR2008A11","AW","Murphy2008",2675265,"Betamethasone","Placebo","NEC","NEC","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MUR2008A12","AW","Murphy2008",2675265,"Betamethasone","Placebo","Composite serious outcome ","\"composite primary outcome\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MUR2008F1","AW","Murphy2008",2675265,"Betamethasone","Placebo","Gestational age at birth","mean GA at birth, >37 weeks, <37 weeks amd <28 weeks reported","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MUR2008F2","AW","Murphy2008",2675265,"Betamethasone","Placebo","SGA","BW <10th centile","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MUR2008F3","AW","Murphy2008",2675265,"Betamethasone","Placebo","Admission to NICU","Admission to NICU","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MUR2008F4","AW","Murphy2008",2675265,"Betamethasone","Placebo","Proven infection whilst in NICU","\"neonatal infection\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MUR2008F7","AW","Murphy2008",2675265,"Betamethasone","Placebo","ROP","ROP","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","High","Some concerns","Some concerns","High"]
["MUR2008F8","AW","Murphy2008",2675265,"Betamethasone","Placebo","PVL","cystic PVL","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Some concerns","Some concerns","Low","Some concerns"]
["MUR2008F10","AW","Murphy2008",2675265,"Betamethasone","Placebo","PDA","PDA needing treatment","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MUR2008F11","AW","Murphy2008",2675265,"Betamethasone","Placebo","Use of respiratory support (any)","\"any ventilatory support\"","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MUR2008F12","AW","Murphy2008",2675265,"Betamethasone","Placebo","Use of invasive respiratory support ","Intubation and ventilation using ET tube","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MUR2008F13","AW","Murphy2008",2675265,"Betamethasone","Placebo","Use of non-invasive respiratory support ","Other ventilatory support without intubation","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low"]
["MUR2008F14","AW","Murphy2008",2675265,"Betamethasone","Placebo","Use of oxygen supplementation","Use of oxygen supplementation","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MUR2008F15","AW","Murphy2008",2675265,"Betamethasone","Placebo","Use of surfactant","Use of surfactant","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MUR2008F17","AW","Murphy2008",2675265,"Betamethasone","Placebo","Use of postnatal corticosteroids","Use of postnatal corticosteroids","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MUR2008F21","AW","Murphy2008",2675265,"Betamethasone","Placebo","Apgar score less than seven at five minutes","Apgar score less than seven at five minutes","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Some concerns","Some concerns"]
["MUR2008L1","AW","Murphy2008",2675265,"Betamethasone","Placebo","Birthweight","Birthweight","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MUR2008L3","AW","Murphy2008",2675265,"Betamethasone","Placebo","HC at birth","HC at birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["MUR2008L4","AW","Murphy2008",2675265,"Betamethasone","Placebo","Length at birth","Length at birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["TEA1999A1","AW","TEAMS1999",2675328,"Betamethasone","Placebo","fetal, neonatal or infant death","death before infant discharge","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","Some concerns","Low","Low","Some concerns","Some concerns"]
["TEA1999A5","AW","TEAMS1999",2675328,"Betamethasone","Placebo","RDS","RDS","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Some concerns","Some concerns","Some concerns"]
["TEA1999A9","AW","TEAMS1999",2675328,"Betamethasone","Placebo","severe IVH","severe IVH","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","Some concerns","Low","Some concerns","Some concerns","Some concerns"]
["TEA1999A11","AW","TEAMS1999",2675328,"Betamethasone","Placebo","NEC","NEC","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","Some concerns","Low","Some concerns","Some concerns","Some concerns"]
["TEA1999A12","AW","TEAMS1999",2675328,"Betamethasone","Placebo","Composite serious outcome ","Composite serious outcome ","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","Some concerns","Low","Some concerns","Some concerns","Some concerns"]
["TEA1999F1","AW","TEAMS1999",2675328,"Betamethasone","Placebo","Gestational age at birth ",">37 weeks, <37 weeks, <28weeks, mean GA at birth","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","Some concerns","Low","Low","Some concerns","Some concerns"]
["TEA1999F4","AW","TEAMS1999",2675328,"Betamethasone","Placebo","Proven neonatal infection while in the NICU","Proven neonatal infection while in the NICU","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","Some concerns","Some concerns","Some concerns","Some concerns","Some concerns"]
["TEA1999F5","AW","TEAMS1999",2675328,"Betamethasone","Placebo","Early systemic neonatal infection ","Early systemic neonatal infection ","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","Some concerns","Low","Some concerns","Some concerns","Some concerns"]
["TEA1999F6","AW","TEAMS1999",2675328,"Betamethasone","Placebo","late systemic neonatal infection ","late systemic neonatal infection ","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","Some concerns","Low","Some concerns","Some concerns","Some concerns"]
["TEA1999F7","AW","TEAMS1999",2675328,"Betamethasone","Placebo","ROP","ROP","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","Some concerns","Low","Some concerns","Some concerns","Some concerns"]
["TEA1999F8","AW","TEAMS1999",2675328,"Betamethasone","Placebo","PVL","PVL","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","Some concerns","Low","Some concerns","Some concerns","Some concerns"]
["TEA1999F10","AW","TEAMS1999",2675328,"Betamethasone","Placebo","PDA","PDA","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","Some concerns","Low","Some concerns","Some concerns","Some concerns"]
["TEA1999F11","AW","TEAMS1999",2675328,"Betamethasone","Placebo","Use of respiratory support ","Use of respiratory support ","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","Some concerns","Low","Low","Some concerns","Some concerns"]
["TEA1999F14","AW","TEAMS1999",2675328,"Betamethasone","Placebo","Use of oxygen supplementation","Use of oxygen supplementation","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","Some concerns","Low","Low","Some concerns","Some concerns"]
["TEA1999F15","AW","TEAMS1999",2675328,"Betamethasone","Placebo","Use of surfactant","Use of surfactant","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","Some concerns","Low","Low","Some concerns","Some concerns"]
["TEA1999F17","AW","TEAMS1999",2675328,"Betamethasone","Placebo","Use of postnatal corticosteroids","Use of postnatal corticosteroids","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","Some concerns","Low","Low","Some concerns","Some concerns"]
["TEA1999F18","AW","TEAMS1999",2675328,"Betamethasone","Placebo","Air leak syndrome","Air leak syndrome","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","Some concerns","Low","Some concerns","Some concerns","Some concerns"]
["TEA1999L1","AW","TEAMS1999",2675328,"Betamethasone","Placebo","BW","BW mean and SD calculated using SE","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","Some concerns","Low","Low","Some concerns","Some concerns"]
["TEA1999L3","AW","TEAMS1999",2675328,"Betamethasone","Placebo","HC at birth","HC at birth mean and SD calculated using SE","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","Some concerns","High","Low","Some concerns","Some concerns"]
["TEA1999L14","AW","TEAMS1999",2675328,"Betamethasone","Placebo","HPA axis function","HPA axis suppression","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Some concerns","Some concerns","Low","Some concerns","Some concerns","Some concerns"]

{"sheet":"Figure (ITT)","index":3,"n_rows":1,"n_cols":13,"rows_kept":1,"cut":false,"hidden":false,"merged":[]}
["Intention-to-treat","Unique ID","Study ID","Experimental","Comparator","Outcome","Weight","D1","D2","D3","D4","D5","Overall"]

{"sheet":"Figure (PP)","index":4,"n_rows":1,"n_cols":13,"rows_kept":1,"cut":false,"hidden":false,"merged":[]}
["Per-protocol","Unique ID","Study ID","Experimental","Comparator","Outcome","Weight","D1","D2","D3","D4","D5","Overall"]

{"sheet":"Print (ITT)","index":5,"n_rows":0,"n_cols":0,"rows_kept":0,"cut":false,"hidden":false,"merged":[]}

{"sheet":"Print (PP)","index":6,"n_rows":0,"n_cols":0,"rows_kept":0,"cut":false,"hidden":false,"merged":[]}

{"sheet":"Check","index":7,"n_rows":2,"n_cols":85,"rows_kept":2,"cut":false,"hidden":false,"merged":[[0,80,0,83],[0,0,0,12],[0,13,0,22],[0,23,0,40],[0,41,0,53],[0,54,0,68],[0,69,0,79]]}
["Basic information",null,null,null,null,null,null,null,null,null,null,null,null,"Domain 1. Randomization process",null,null,null,null,null,null,null,null,null,"Domain 2. Deviations from intended interventions",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Domain 3. Mising outcome data",null,null,null,null,null,null,null,null,null,null,null,null,"Domain 4. Measurement of the outcome",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Domain 5. Selection of the reported result",null,null,null,null,null,null,null,null,null,null,"Domain 6. Overall Bias"]
["Time","Unique ID","Assessor","Study ID","Reference","Experimental","Comparator","Outcome","Results","Aim","Effect of adhering to intervention?","Weight","Sources","1.1","1.2","Note for 1.1&1.2","1.3","Note for 1.3","1.0 Algorithm result","1.0 Assessor's Judgement","1.0 General note","1.0 Optional Question","1.0 Note for optional question","2.1","2.2","Note for 2.1&2.2","2.3","Note for 2.3","2.4","Note for 2.4","2.5","Note for 2.5","2.6","Note for 2.6","2.7","Note for 2.7","2.0 Algorithm result","2.0 Assessor's Judgement","2.0 General Notes","2.0 Optional Question","2.0 Note for optional question","3.1","Note for 3.1","3.2","Note for 3.2","3.3","Note for 3.3&3.4","3.4","Note for 3.4 (not use)","3.0 Algorithm result","3.0 Assessor's judgement","3.0 Gerenal notes","3.0 Optional Question","3.0 Note for optional question","4.1","Note for 4.1","4.2","Note for 4.2","4.3","Note for 4.3","4.4","Note for 4.4&4.5","4.5","Note for 4.5 (not use)","4.0 Algorithm result","4.0 Assessor's Judgement","4.0 General note","4.0 Optional Question","4.0 Note for optional question","5.1","Note for 5.1","5.2","Note for 5.2","5.3","Note for 5.3","5.0 Algorithm result","5.0 Assessor's Judgement","5.0 General note","5.0 Optional Question","5.0 Note for optional question","Algorithm's overall Judgement","Assessor's overall Judgement","6.0 General Note","6.0 Optional Question","6.0 Note for optional question"]

{"sheet":"Print_format (PP)","index":8,"n_rows":32,"n_cols":6,"rows_kept":32,"cut":false,"hidden":true,"merged":[[18,5,19,5],[24,5,25,5],[4,1,4,3],[5,0,8,0],[5,1,5,3],[5,5,6,5],[6,1,6,3],[7,1,7,3],[8,1,8,3],[9,5,10,5],[10,1,10,3],[11,1,11,3],[12,1,12,3],[13,1,13,3],[9,0,15,0],[9,1,9,3],[14,1,14,3],[15,1,15,3],[16,0,20,0],[16,1,16,3],[17,1,17,3],[18,1,18,3],[20,1,20,3],[19,1,19,3],[31,1,31,3],[21,0,26,0],[21,1,21,3],[22,1,22,3],[26,1,26,3],[23,1,23,3],[25,1,25,3],[24,1,24,3],[29,1,29,3],[27,0,30,0],[27,1,27,3],[28,1,28,3],[30,1,30,3]]}
["Unique ID",null,"Study ID",null,"Assessor"]
["Ref or Label",null,"Aim","adhering to intervention (the 'per-protocol' effect)","The effect of adhering to intervention…"]
["Experimental",null,"Comparator",null,"Source"]
["Outcome",null,"Results",null,"Weight"]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?"]
[null,"Risk of bias judgement"]
["Bias due to deviations from intended interventions","2.1 Were participants aware of their assigned intervention during the trial?"]
[null,"2.2 Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?"]
[null,"2.3. [If applicable:] If Y/PY/NI to 2.1 or 2.2: Were important non-protocol interventions balanced across intervention groups?"]
[null,"2.4. [If applicable:] Were there failures in implementing the intervention that could have affected the outcome?"]
[null,"2.5. [If applicable:] Was there non-adherence to the assigned intervention regimen that could have affected participants’ outcomes?"]
[null,"2.6. If N/PN/NI to 2.3, or Y/PY/NI to 2.4 or 2.5: Was an appropriate analysis used to estimate the effect of adhering to the intervention?"]
[null,"Risk of bias judgement"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?"]
[null,"Risk of bias judgement"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?"]
[null,"Risk of bias judgement"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?"]
[null,"5.3 ... multiple eligible analyses of the data?"]
[null,"Risk of bias judgement"]
["Overall bias","Risk of bias judgement"]

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["Unique ID",null,"Study ID",null,"Assessor"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental",null,"Comparator",null,"Source"]
["Outcome",null,"Results",null,"Weight"]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?"]
[null,"Risk of bias judgement"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?"]
[null,"Risk of bias judgement"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?"]
[null,"Risk of bias judgement"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?"]
[null,"Risk of bias judgement"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?"]
[null,"5.3 ... multiple eligible analyses of the data?"]
[null,"Risk of bias judgement"]
["Overall bias","Risk of bias judgement"]

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[null,"Journal article(s)","NA","Yes",null,"1.1 Was the allocation sequence random?",null,"2.1 Were participants aware of their assigned intervention during the trial?","2.1 Were participants aware of their assigned intervention during the trial?",null,"3.1 Were data for this outcome available for all, or nearly all, participants randomized?","Individually Randomized, Parallel Group Trials","4.1 Was the method of measuring the outcome inappropriate?","assignment to intervention (the 'intention-to-treat' effect)","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,null,"occurance of non-protocol interventions"]
["NA","Trial protocol","Favours experimental ","No (Please include reasons in the note)","Y","1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?","Low","2.2 Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?","2.2 Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,"3.2 If N/PN/NI to 3.1: Is there evidence that the result was not biased by missing outcome data?",null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?","adhering to intervention (the 'per-protocol' effect)","5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,null,"failures in implementing the intervention that could have affected the outcome"]
["Y","Statistical analysis plan (SAP)","Favours comparator ",null,"PY","1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?","High","2.3 [If applicable:] If Y/PY/NI to 2.1 or 2.2: Were important nonprotocol interventions balanced across intervention groups?","2.3 If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the trial context?",null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,"4.3 If N/PN/NI to 4.1 and 4.2: Were outcome assessors aware of the intervention received by study participants?",null,"5.3 ... multiple eligible analyses of the data?",null,null,null,"non-adherence to their assigned intervention by trial participants"]
["PY","Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Towards null ",null,"PN",null,"Some concerns","2.4 [If applicable:] Were there failures in implementing the intervention that could have affected the outcome?","2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?"]
["PN","Company-owned trial registry record (e.g. GSK Clinical Study Register record)","Away from null ",null,"N",null,null,"2.5 [If applicable:] Was there non-adherence to the assigned intervention regimen that could have affected participants’ outcomes?","2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?"]
["N","“Grey literature” (e.g. unpublished thesis)","Unpredictable",null,"NI",null,null,"2.6 If N/PN/NI to 2.3, or Y/PY/NI to 2.4 or 2.5: Was an appropriate analysis used to estimate the effect of adhering to the intervention?","2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?"]
["NI","Conference abstract(s) about the trial",null,null,null,null,null,null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?"]
[null,"Regulatory document (e.g. Clinical Study Report, Drug Approval Package)"]
[null,"Research ethics application"]
[null,"Grant database summary (e.g. NIH RePORTER, Research Councils UK Gateway to Research)"]
[null,"Personal communication with trialist"]
[null,"Personal communication with the sponsor"]