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ARTERIAL US Study Data Dictionary

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posted on 2023-07-20, 08:34 authored by Robyn MayRobyn May, Frank BloomfieldFrank Bloomfield, Tom GentlesTom Gentles

This is the metadata for a clinical dataset entitled the The ARTERIAL US Study (A pReTERm Infants’ cArdiovascular deveLopment: An Ultrasound Study). We collected cardiovascular ultrasound data on the geometry, heart size, blood vessel diameters) and function (Doppler flow waveforms) of term and preterm hearts and vasculature. 


Study design: 

The ARTERIAL US Study is a single-centre prospective observational cohort study.


Study synopsis

Participants:

1. Term group: babies born at or after 37+0 weeks gestation

2. Late preterm group: babies born at or after 34+0 and before 37+0 weeks gestation


Primary Outcome(s): Haemodynamic status as computed by the computational model of the neonatal cardiovascular system

Sample Size: 15 term and 10 late preterm

Study Setting: Auckland City Hospital, Te Toka Tumai Auckland (formerly Auckland District Health Board)


Eligibility criteria

Inclusion criteria:

  • Born at or after at or after 37+0 weeks gestation (term group) or born at or after 34+0 and before 37+0 weeks gestation (late preterm group),
  • Parental consent

Exclusion criteria:

  • Known medical conditions or cardiovascular abnormalities.


Data collection

Methods: Babies will have an ultrasound examination within 48 hours of birth and again three to six weeks later weeks later (i.e., at term equivalent postmenstrual age). Data collection included clinical data collection (data from the medical records about the following clinical factors: antenatal admission to hospital, gestational diabetes mellitus, antenatal infection, placental:fetal weight ratio, exposure to antenatal corticosteroids and magnesium sulphate, risk factors and primary reason for preterm birth (including pre-eclampsia, chorioamnionitis and fetal growth restriction), age at scan, sex, gestational age at birth, birth weight and length, head circumference at birth, APGARs, delayed cord clamping, postnatal steroid administration), anthropometric measurements and ultrasound measurements.


Data availability

Data and associated documentation from participants who have consented to future re-use of their data are available to other users under the data sharing arrangements provided by the University of Auckland’s Human Health Research Services (HHRS) platform (https://research-hub.auckland.ac.nz/subhub/human-health-research-services-platform). The data dictionary and metadata are published on the here. Researchers are able to use this information and the provided contact address (dataservices@auckland.ac.nz) to request a de-identified dataset through the HHRS Data Access Committee. Data will be shared with researchers who provide a methodologically sound proposal and have appropriate ethical approval, where necessary, to achieve the research aims in the approved proposal. Data requestors are required to sign a Data Access Agreement that includes a commitment to using the data only for the specified proposal, not to attempt to identify any individual participant, a commitment to secure storage and use of the data, and to destroy or return the data after completion of the project. The HHRS platform reserves the right to charge a fee to cover the costs of making data available, if needed, for data requests that require additional work to prepare.

Funding

1220006 Auckland Medical Research Foundation

History

Publisher

University of Auckland

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