Learning the right lessons from the SUPPORT study controversy.

Ten years ago, there was well-known and widespread practice variation in the levels of oxygen that neonatologists provided to premature babies.1 Neonatal intensive care units (NICUs) targeted oxygen saturations ranging from 82% to 100%. Cole and colleagues summarised the state of knowledge about oxygen therapy for premature babies: “We do not understand optimal oxygenation management in extremely low gestational age neonates (<28 weeks’ gestation). No randomised controlled trial has clarified the relation between retinopathy of prematurity and blood oxygen, transcutaneous oxygen or oxygen saturation levels.”2 As a result, they noted, “neonatal care providers differ widely, with no consensus in their policies, practices and strong beliefs regarding oxygen management in the early and later neonatal courses of premature infants.” They called for prospective randomised trials to address this crucial gap in knowledge, because “continued treatment of millions of premature infants in ignorance of what is safe and effective oxygenation is not an option.”

Today, the situation is different because such studies were designed and conducted in the USA,3 Canada,4 Australia, New Zealand and the UK.5 In the USA, the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) was a National Institutes of Health (NIH)-sponsored, multicentre, prospective randomised trial of different strategies to treat lung disease in babies born at 24–27 weeks of gestation. Between 2004 and 2009, approximately 1300 infants were enrolled. The study led to a number of seminal papers that today, at long last, allow oxygen therapy to be evidence based. Babies are safer as a result.

Now, questions are being raised about whether the studies harmed the babies who participated and about whether parents were fully informed about the risks of those studies. On 7 March, the Office of Human Research Protections (OHRP) notified the researchers in SUPPORT that “…the conduct of this study was in …