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

Leeann R. Pavlek; Brian K. Rivera; Charles V. Smith; Joanie Randle; Cory Hanlon; Kristi Small; Edward F. Bell; Matthew A. Rysavy; Sara Conroy; Carl H. Backes

doi:10.1016/j.jpeds.2021.04.028

Back

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

Journal article

Open access

Peer reviewed

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

Leeann R. Pavlek, Brian K. Rivera, Charles V. Smith, Joanie Randle, Cory Hanlon, Kristi Small, Edward F. Bell, Matthew A. Rysavy, Sara Conroy and Carl H. Backes

The Journal of pediatrics, Vol.235, pp.63-74.e12

08/2021

DOI: 10.1016/j.jpeds.2021.04.028

PMCID: PMC9348995

PMID: 33894262

Files and links (1)

url

https://doi.org/10.1016/j.jpeds.2021.04.028View

Published (Version of record) Open Access

Abstract

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.

exclusion criteria

inclusion criteria

premature infant

Details

Title: Subtitle: Eligibility Criteria and Representativeness of Randomized Clinical Trials That Include Infants Born Extremely Premature: A Systematic Review
Creators: Leeann R. Pavlek - The Ohio State University Wexner Medical Center
Brian K. Rivera - Nationwide Children's Hospital
Charles V. Smith - Seattle Children's Research Institute
Joanie Randle - Nationwide Children's Hospital
Cory Hanlon - Nationwide Children's Hospital
Kristi Small - Nationwide Children's Hospital
Edward F. Bell - University of Iowa
Matthew A. Rysavy - University of Iowa
Sara Conroy - The Ohio State University
Carl H. Backes - Nationwide Children's Hospital
Resource Type: Journal article
Publication Details: The Journal of pediatrics, Vol.235, pp.63-74.e12
DOI: 10.1016/j.jpeds.2021.04.028
PMID: 33894262
PMCID: PMC9348995
NLM abbreviation: J Pediatr
ISSN: 0022-3476
eISSN: 1097-6833
Publisher: Elsevier Inc
Grant note: Ohio Perinatal Research Network
Language: English
Date published: 08/2021
Academic Unit: Stead Family Department of Pediatrics; Neonatology
Record Identifier: 9984354005202771

Metrics

4 Record Views

15 Times Cited - Web of Science