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

Objective To assess the eligibility criteria and trial characteristics among contemporary (2010-2019) randomized clinical trials (RCTs) that included extremely preterm infants ( Study design PubMed and Scopus were searched 01/01/2010-12/31/2019 with no language restrictions. RCTs with mean or median gestational ages at birth of Results Among 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 Conclusions The 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.