Ethical Support for Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT)

Abstract

From the Case Western Reserve University School of Medicine and the Division of Neonatology, Rainbow Babies and Children’s Hospital/University Hospitals Case Medical Center; and the Rainbow Center for Pediatric Ethics, Rainbow Babies & Children’s Hospital/University Hospitals Case Medical Center, Cleveland, Ohio Randomized Trial (SUPPORT). The randomized study involved 23 major academic centers (including the institution in which I am employed) and was designed to determine the appropriate range of oxygen saturation in extremely preterm infants. This was done by using 2 target ranges of oxygen saturation (low, 85%-89%, and high, 91%-95%). According to Public Citizen’s letter to Department of Health and Human Services Secretary Kathleen Sebelius, the vulnerable infants were subject to “highly unethical” (page 1) and “indefensible” (page 11) research. Parents were deceived into enrolling their infants via “egregious” (page 3) deficiencies in the informed consent process. The letter closes by demanding a “formal apology” (page 11) to all 1316 patients who were enrolled in the study. Public Citizen has grossly distorted what was “known” about treating premature infants at the time of the study. Unfortunately, the use of oxygen in neonatology has a long and tragic history. As early as 1900, oxygen was recommended for premature infants during episodes of cyanosis. Early incubators were flooded with oxygen even though it was recognized that there was no “convincing evidence that an increased oxygen content of arterial blood is beneficial or necessarily of importance.” Additionally, there was no way at this time to quickly and noninvasively measure the baby’s oxygen levels or saturation. By the 1950s, it was recognized that too much oxygen led to blindness in the form of retrolental fibroplasia. Indeed, this was the cause of famous preemie Stevie Wonder’s blindness. After this discovery, oxygen use was restricted and the outcome was disastrous– death and cerebral palsy rates sharply increased. Later calculations estimated that for every infant who kept his sight, 16 infants died. In the following decades, the field of neonatology saw remarkable progress. The discovery of surfactant and widespread adoption of antenatal corticosteroids, better nutrition, gentler ventilators, and care provided by specially