Development, Design, and Sample Composition

Abstract

Following its introduction in 1947 for treatment of erythroblastosis fetalis and in 1949 for hyperbilirubinemia, exchange transfusion became accepted as the most effective means of preventing increasing serum bilirubin concentrations in the newborn infant from reaching a hazardous level.² At that time, there was general agreement that the risk of bilirubin encephalopathy increased when serum bilirubin concentrations exceeded 20 mg/dL of serum and that this risk became greater with increasing concentrations. The safety of exchange transfusion was assessed by Boggs and Westphal¹⁴ in 1960 and found acceptable for that time.

In 1958, Cremer et al²² reported a distinct lowering of serum bilirubin levels in infants exposed to direct sunlight. This observation was followed by development of light sources for exposure of infants to treat or prevent hyperbilirubinemia (phototherapy).

Although phototherapy had been used and reported in Europe and South America, it was not until 1968 that the first study⁶⁴ appeared in the pediatric literature of the United States. Other studies^36,41,83 followed and suggested a potential role for phototherapy in the management of hyperbilirubinemia of the newborn infant. However, these studies suffered from lack of a sufficient number of patients to accommodate appropriate statistical adjustment procedures for the many known confounding variables. Also, these studies had inadequate numbers of control infants and phototherapy-treated infants who were followed long enough to perform evaluations of the impact of the mode of therapy on such parameters as hearing, sight, speech, IQ, and behavioral performance.^31,74

DEVELOPMENT OF THE STUDY

In May 1972, the National Research Council of the National Academy of Sciences established a Committee on Phototherapy in the Newborn.