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Retrospective consent in clinical trials significantly increased infant recruitment compared to prospective consent. While altering participant characteristics, retrospective consent may enhance the representativeness and scientific validity of study samples.

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Area of Science:

  • Neonatal Medicine
  • Clinical Trial Methodology
  • Bioethics

Background:

  • Prospective consent in acute settings can lead to unrepresentative samples in clinical trials.
  • Retrospective consent presents ethical considerations but may improve sample representativeness.
  • The impact of retrospective consent on recruitment and participant characteristics requires investigation.

Purpose of the Study:

  • To assess the effect of retrospective consent on recruitment rates in a randomized controlled trial (RCT).
  • To evaluate differences in participant characteristics between prospective and retrospective consent eras.
  • To determine if retrospective consent influenced study outcomes in preterm infants.

Main Methods:

  • Secondary analysis of an RCT comparing nasal high flow (nHF) and nasal continuous positive airway pressure (CPAP) in preterm infants.
  • Comparison of two consent eras: Era 1 (prospective consent) and Era 2 (retrospective consent).
  • Assessment of inclusion rates, demographic data, and treatment failure within 72 hours.

Main Results:

  • Recruitment rates were significantly higher with retrospective consent (82%) versus prospective consent (50%).
  • Participant characteristics differed between eras, including lower intrapartum antibiotic use and higher antenatal steroid use with prospective consent.
  • Treatment failure rates showed no significant interaction between consent era and treatment group (nHF vs. CPAP).

Conclusions:

  • Retrospective consent substantially improved recruitment in this neonatal RCT.
  • The use of retrospective consent altered the study sample, potentially increasing its representativeness.
  • Further ethical evaluation is needed to balance improved scientific validity with consent practices.