Eligibility Criteria and Representativeness of Randomized Clinical Trials That Include Infants Born Extremely Premature: A Systematic Review - 22/07/21
Abstract |
Objective |
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).
Study design |
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.
Results |
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.
Conclusions |
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.
Le texte complet de cet article est disponible en PDF.Key words : inclusion criteria, exclusion criteria, premature infant
Abbreviation : RCT
Plan
| Funded by the Ohio Perinatal Research Network (OPRN) within the Nationwide Children's Hospital Abigail Wexner Research Institute. The authors declare no conflicts of interest. |
Vol 235
P. 63 - août 2021 Retour au numéro
Article précédent
- 50 Years Ago in The Journal of Pediatrics : Advances in the Understanding of Congenital Hyperinsulinemic Hypoglycemia
- Alecia Thompson-Branch, Tomas Havranek
- Cerebral Oxygenation and Perfusion when Positioning Preterm Infants: Clinical Implications
- Pranav R. Jani, Krista Lowe, Aldo Perdomo, Lorraine Wakefield, Murray Hinder, Claire Galea, Traci–Anne Goyen, Robert Halliday, Karen Ann Waters, Nadia Badawi, Mark Tracy
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?