Retrospective consent in a neonatal randomized controlled trial

Abstract

Background and Objectives: The requirement for prospective consent in clinical trials in acute settings may result in samples unrepresentative of the study population, potentially altering study findings. However, using retrospective consent may raise ethical issues. We assessed whether using retrospective consent affected recruitment, participant characteristics, and outcomes within a randomized controlled trial. Methods: We conducted a secondary analysis of a randomized trial, which compared nasal high flow (nHF) with nasal continuous positive airway pressure (CPAP) for primary respiratory support in preterm infants. In Era 1, all infants were consented prospectively; in Era 2, retrospecti..