AI Article Synopsis
- - The study aimed to evaluate eligibility criteria and characteristics of randomized clinical trials (RCTs) from 2010 to 2019 that focused on infants born extremely preterm (<28 weeks of gestation), checking for potential underrepresentation of high-risk groups, especially those born before 24 weeks.
- - A total of 201 RCTs were analyzed, involving over 32,000 infants, revealing substantial variability in participant characteristics, interventions, and outcomes, with only a small percentage of trials including infants born <24 weeks.
- - The findings highlight the inconsistency in eligibility criteria across RCTs and emphasize the necessity for improved and transparent policy standards to ensure better representation of high-risk infant subgroups in future research. *
Article Abstract
Objective: To assess the eligibility criteria and trial characteristics among contemporary (2010-2019) randomized clinical trials (RCTs) that included infants born extremely preterm (<28 weeks of gestation) and to evaluate whether eligibility criteria result in underrepresentation of high-risk subgroups (eg, infants born at <24 weeks of gestation).
Study Design: PubMed and Scopus were searched January 1, 2010, to December 31, 2019, with no language restrictions. RCTs with mean or median gestational ages at birth of <28 weeks of gestation were included. The study followed the PRISMA guidelines; outcomes were registered prospectively. Data extraction was performed independently by multiple observers. Study quality was evaluated using a modified Jadad scale.
Results: Among RCTs (n = 201), 32 552 infants were included. Study participant characteristics, interventions, and outcomes were highly variable. A total of 1603 eligibility criteria were identified; rationales were provided for 18.8% (n = 301) of criteria. Fifty-five RCTs (27.4%) included infants <24 weeks of gestation; 454 (1.4%) infants were identified as <24 weeks of gestation.
Conclusions: The present study identifies sources of variability across RCTs that included infants born extremely preterm and reinforces the critical need for consistent and transparent policies governing eligibility criteria.
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Source |
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9348995 | PMC |
| http://dx.doi.org/10.1016/j.jpeds.2021.04.028 | DOI Listing |
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