Is the Newborn Surfactant Synthesis Study Ethical?

On June 28, 2005, the Food and Drug Administration (FDA) will discuss the ethics of a study of surfactant synthesis in newborns. Supported by the National Heart, Lung & Blood Institute, the study "proposes to administer simultaneous 24-hour infusions of stable carbon-13 labeled palmitate and acetate and measure the incorporation of each into surfactant in the lungs of preterm and full-term newborns.

The study, entitled "Precursor Preference in Surfactant Synthesis of Newborns", would be regulated by the FDA and conducted or supported by the Human Research Protections (HHS). Enrollment of 15 – 20 preterm infants with respiratory distress syndrome and 10 full-term infants with normal lungs is planned.

Infant respiratory distress syndrome (IRDS) is the 6th most common cause of newborn death in the U.S. It occurs in premature infants because the immature lungs lack surfactant, a substance that acts as a lubricant to reduce surface tension and prevent collapsing of the alveoli in the lungs.

The aim of the study is threefold: 1) to determine the rate of surfactant synthesis using de novo synthesized fatty acids (acetate), 2) to determine the rate of surfactant synthesis using preformed fatty acids (palmitate), and 3) to compare the rates of incorporation in preterm infants versus term infants with normal lungs.

The study was previously rejected by the Washington University Investigational Review Board (IRB) "because [the study] poses more than minimal risks to the subjects [and] there is no prospect of direct benefit to the individual subjects", states the FDA.

The FDA is seeking public comment on the ethics of this study. To submit your comment on this docket, go to Dockets Open for Comment, click on Docket Search, and enter Docket ID: 2005N-0184.