Resolving Our Uncertainty About Oxygen Therapy

Win Tin1 eloquently articulated in his editorial “Oxygen Therapy: 50 Years of Uncertainty” that neonatal care providers do not understand how best to use oxygen in the most vulnerable premature infants despite >50 years of oxygen therapy in neonatal medicine.1 We do not understand optimal oxygenation management in extremely low gestational age neonates (<28 weeks’ gestation), because we do not know what are safe and effective upper and lower limits of oxygen levels or saturation ranges in both the early and later neonatal courses.1–7 There has been no implementation of the most powerful tool in clinical research, the randomized, controlled trial, to resolve the uncertainty since the early clinical trials in the 1950s.8–15 No randomized control trial has clarified the relation between retinopathy of prematurity (ROP) and blood oxygen (Pao2), transcutaneous oxygen (tco2), or oxygen saturation (Spo2) levels. Furthermore, the effects of “higher” versus “lower” oxygen levels or saturation ranges on ROP, growth, brain, lung, and other organ systems have not been studied with respect to gestational age, time of onset or duration of specified oxygen level or saturation range, or method of oxygen termination. Because of the lack of definitive evidence on which to base policy, 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.2,16–20 Thus, the study of oxygen therapy in the neonatal population at highest risk for oxygen-related morbidities is an extremely important and urgent issue. We strongly agree with Tin1,2,16 and others18–22 that an adequately powered, large, randomized, controlled trial must be conducted to resolve the uncertainty and determine … Address correspondence to Cynthia H. Cole, MD, MPH, Division of Newborn Medicine, Floating Hospital for Children, Tufts-New England Medical Center, 750 Washington St, Boston, MA 02111. E-mail: ccole{at}tufts-nemc.org