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Are we enrolling representative cohorts of premature infants in our clinical trials?

Adithya Shastry1, Barbara Bajuk2, Mohamed E Abdel-Latif3,4,5

  • 1Medical School, ANU College of Health and Medicine, Australian National University, Acton, ACT, Australia.

Journal of Perinatology : Official Journal of the California Perinatal Association
|September 14, 2021
PubMed

Insights

Infants eligible but not enrolled in The Australian Placental Transfusion Study (APTS) faced higher risks of mortality and morbidity. Retrospective consent may improve trial generalizability in neonatal research.

Area of Science:

  • Neonatal research
  • Clinical trial methodology
  • Perinatal medicine

Background:

  • The Australian Placental Transfusion Study (APTS) aimed to evaluate placental transfusion in infants.
  • Understanding the characteristics and outcomes of infants eligible but not enrolled (ENE) is crucial for trial generalizability.

Purpose of the Study:

  • To compare outcomes between infants eligible and enrolled (EE) versus eligible but not enrolled (ENE) in the APTS.
  • To assess the impact of antenatal consenting on population representation in neonatal clinical trials.

Main Methods:

  • Retrospective cohort study design.
  • Involved a population-based, multicentre analysis of APTS participants.
  • Compared anthropometric measures, prematurity, and clinical outcomes between EE and ENE infant groups.

Main Results:

  • Significantly higher prematurity observed in ENE infants (mean gestation 27.0 weeks) compared to EE infants (28.0 weeks).
  • ENE infants exhibited increased incidences of low Apgar scores, chronic lung disease (CLD), intraventricular hemorrhage (IVH), and patent ductus arteriosus (PDA) requiring treatment.
  • Multivariate analysis indicated a greater risk of mortality for ENE infants (OR 1.86; 95% CI, 1.30-2.67).

Conclusions:

  • Antenatal consenting for clinical trials can introduce bias in population representation, potentially limiting the generalizability of results.
  • Implementing retrospective consent or waiver of consent procedures may enhance the generalizability of findings in neonatal and emergency clinical trials.
Abstract

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