SUPPORTing Premature Infants

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* Abbreviations: OHRP — : Office for Human Research Protections SUPPORT — : Surfactant Positive Pressure, and Oxygenation Randomized Trial The Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) tried to determine the safest dose of oxygen for premature infants. The federal Office for Human Research Protections (OHRP) determined that the consent process for the study violated federal regulations by failing to inform parents of “reasonably foreseeable risks” of death or blindness.1 The New York Times agreed, calling these failures “startling and deplorable.2 The New England Journal disagreed. They found the consent forms adequate and the accused the OHRP of “casting a pall over the conduct of clinical research.”3 Leaders of the NIH agreed.4 The difference of opinion turns, in part, on the ways that we define the relative risks of research, on the one hand, and, on the other hand, the risks of widely used but inadequately studied conventional therapies. Ten years ago, Cole et al5 summarized the state of knowledge about oxygen therapy for premature infants: “We do not understand optimal oxygenation management in extremely low gestational age neonates (<28 weeks’ gestation). No randomized controlled trial has clarified the relation between retinopathy of prematurity and blood oxygen, transcutaneous oxygen, or oxygen saturation levels.” As a result, they noted, “neonatal care providers differ widely, with no consensus in their policies, practices, and strong beliefs regarding oxygen management in both the early and later neonatal courses of premature infants.” They called for prospective randomized 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 United States,6 Canada, Australia, New Zealand, and the United Kingdom.7 In the United States, SUPPORT was a National Institutes of Health–sponsored, multicenter, prospective randomized trial of … Address correspondence to John D. Lantos, MD, Children’s Mercy Hospital, 2401 Gillham Rd, Kansas City, MO 64108. E-mail: jlantos{at}cmh.edu