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Vohra et al present the results of a secondary analysis of the Vermont Oxford Network Heat-Loss Prevention (HeLP) Trial. The HeLP trial examined use of polyethylene wrap in the delivery room (DR), to reduce mortality in extremely preterm infants.1 More than 800 infants from 38 centres across the USA and Canada were enrolled. The study stopped at 50% recruitment, on grounds of futility. All centres used prospective antenatal consent, four sites also used a consent waiver. Seventeen per cent of recruits (n=133) were enrolled via waived consent. Vohra’s analysis evaluates whether the consent mode used was associated with differences in recruits.
Neonatal resuscitation research unfortunately lags behind other areas, largely due to the complexities of conducting DR studies meaning that many DR interventions have never been rigorously tested. The Declaration of Helsinki guides all research consent; but gaining ethically appropriate antenatal parental consent for DR research is challenging. Antenatal consent is not always possible, and researchers must avoid duress resulting from time pressure or parental distress.
Vohra rightly notes that restricting recruits for DR studies to only those in whom antenatal consent is possible, results in systematic exclusion of an important subset of the population, an effect highlighted by a secondary analysis of the SUPPORT Study (Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial).2 SUPPORT required antenatal consent for DR interventions, and recruited infants with fewer risk factors than those eligible but not recruited. Enrolled infants were born in better condition and had better outcomes, with the differences attributable to differences in their birth characteristics.2 Dependence on antenatal consent resulted in biased enrolment; enrolled infants came from a lower-risk subset of the eligible population who were more likely to do well. Infants at highest risk of adverse outcome were excluded. …
Correction notice This article has been corrected since it first published. The provenance and peer review statement has been included.
Contributors LSO conceived, wrote and edited the first and final drafts of this manuscript. PGD contributed to and edited the manuscript.
Funding This study was funded by the National Health and Medical Research Council, grant number: (105911,1113902,1159444).
Competing interests None declared.
Provenance and peer review Commissioned; externally peer reviewed.
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