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Eligibility Criteria and Representativeness of Randomized Clinical Trials That Include Infants Born Extremely

Leeann R Pavlek1, Brian K Rivera2, Charles V Smith3

  • 1Center for Perinatal Research, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, OH; Department of Pediatrics, The Ohio State University Wexner Medical Center, Columbus, OH.

The Journal of Pediatrics
|April 24, 2021
PubMed

Insights

Eligibility criteria in randomized clinical trials for extremely preterm infants are highly variable and often exclude high-risk subgroups, such as those born before 24 weeks of gestation. This highlights the need for consistent policies in clinical research.

Area of Science:

  • Neonatal research
  • Clinical trial methodology
  • Perinatal medicine

Background:

  • Randomized clinical trials (RCTs) are crucial for advancing care for extremely preterm infants (born <28 weeks gestation).
  • Variability in trial eligibility criteria may impact the generalizability of findings and exclude vulnerable populations.
  • High-risk subgroups, such as infants born before 24 weeks gestation, may be underrepresented.

Purpose of the Study:

  • To assess eligibility criteria and trial characteristics in RCTs involving extremely preterm infants from 2010-2019.
  • To evaluate if current eligibility criteria lead to the underrepresentation of high-risk subgroups.
  • To identify sources of variability in trial design and participant selection.

Main Methods:

  • Searched PubMed and Scopus databases (2010-2019) for RCTs including infants born <28 weeks gestation.
  • Followed PRISMA guidelines for study selection and data extraction.
  • Assessed study quality using a modified Jadad scale.

Main Results:

  • Analyzed 201 RCTs involving 32,552 extremely preterm infants.
  • Identified 1603 eligibility criteria, with rationales provided for only 18.8%.
  • Found that only 27.4% of RCTs included infants <24 weeks gestation, representing just 1.4% of all included infants.

Conclusions:

  • Significant variability exists in eligibility criteria across RCTs for extremely preterm infants.
  • Current criteria may lead to the exclusion of high-risk infants, limiting research generalizability.
  • There is a critical need for consistent and transparent policies governing eligibility criteria in neonatal RCTs.
Abstract

Keywords:
exclusion criteriainclusion criteriapremature infant

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