Eligibility Criteria and Representativeness of Randomized Clinical Trials That Include Infants Born Extremely Premature: A Systematic Review.
exclusion criteria
inclusion criteria
premature infant
Journal
The Journal of pediatrics
ISSN: 1097-6833
Titre abrégé: J Pediatr
Pays: United States
ID NLM: 0375410
Informations de publication
Date de publication:
Aug 2021
Aug 2021
Historique:
received:
06
01
2021
revised:
23
03
2021
accepted:
15
04
2021
pubmed:
25
4
2021
medline:
23
11
2021
entrez:
24
4
2021
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 33894262
pii: S0022-3476(21)00354-1
doi: 10.1016/j.jpeds.2021.04.028
pmc: PMC9348995
mid: NIHMS1823121
pii:
doi:
Types de publication
Journal Article
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
63-74.e12Subventions
Organisme : NICHD NIH HHS
ID : L40 HD099827
Pays : United States
Informations de copyright
Copyright © 2021 Elsevier Inc. All rights reserved.
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