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

• Published in: The Journal of pediatrics Vol. 235; pp. 63 - 74.e12
• Main Authors: Pavlek, Leeann R., Rivera, Brian K., Smith, Charles V., Randle, Joanie, Hanlon, Cory, Small, Kristi, Bell, Edward F., Rysavy, Matthew A., Conroy, Sara, Backes, Carl H.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-08-2021
• Subjects: exclusion criteria; inclusion criteria; premature infant; inclusion criteria; RCT; exclusion criteria; premature infant
• ISSN: 0022-3476; 1097-6833
• DOI: 10.1016/j.jpeds.2021.04.028

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).
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.
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.
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.