Alternative consent processes in a neonatal resuscitation trial (SAIL): secondary analysis of an open-label, international, multicentre, randomised trial
Abstract
Summary Background Delivery room trials face ethical and logistical enrolment challenges, including requirements for prospective, antenatal, parental consent. The Sustained Aeration of Infant Lungs (SAIL) study was a randomised controlled trial of two resuscitation strategies at birth, enrolling infants using both prospective antenatal consent and deferred postnatal (consent-to-continue) pathways. We aimed to compare recruitment and outcomes between SAIL trial centres with deferred consent available versus centres only using prospective antenatal consent. Method This study is a secondary analysis of the data from the open-label, international, multicentre, randomised SAIL trial. Infants born at 23 to less than 27 weeks’ gestation at 18 centres across nine countries who were deemed to require intermittent positive pressure ventilation due to inadequate respiratory efforts or bradycardia, had no known major congenital anomalies, and were neither stillborn nor considered to be non-viable by their clinician were eligible for inclusion. Centres were compared by consent mode availability: antenatal consent only versus centres with deferred consent available. The primary outcome was the combined rate of death or bronchopulmonary dysplasia compared between consent type groups. People with lived experience did not contribute to the design or implementation of the SAIL trial. The SAIL trial was registered with ClinicalTrials.gov (NCT02139800). Findings The SAIL trial recruited 426…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 479 participants or records.
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