Eligibility Criteria and Representativeness of Randomized Clinical Trials That Include Extremely Premature Infants: A Systematic Review.

Abstract

OBJECTIVE\nTo assess the eligibility criteria and trial characteristics among contemporary (2010-2019) randomized clinical trials (RCTs) that included extremely preterm infants (<28 weeks of gestation), and to evaluate whether eligibility criteria result in underrepresentation of high-risk subgroups (eg, infants born at <24 weeks gestation).\n\n\nSTUDY DESIGN\nPubMed and Scopus were searched 01/01/2010-12/31/2019 with no language restrictions. RCTs with mean or median gestational ages at birth of <28 weeks of gestation were included. The study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses; outcomes were registered prospectively. Data extraction was performed independently by multiple observers. Study quality was evaluated using a modified Jadad scale.\n\n\nRESULTS\nAmong RCTs (n=201), 32,552 infants were included. Study participant characteristics, interventions, and outcomes were highly variable. A total of 1,603 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.\n\n\nCONCLUSIONS\nThe present study identifies sources of variability across RCTs that included extremely preterm infants and reinforces the critical need for consistent and transparent policies governing eligibility criteria.