This study, which began in 1974, is a cooperative, randomized clinical trial to determine the safety and efficacy of phototherapy for treatment of neonatal hyperbilirubinemia by comparing phototherapy with non-phototherapy infants under specific conditions. Babies were randomized by weight (less than 2,000, 2,000 -2,499 and greater than 2,499 grams) to the phototherapy or non-phototherapy groups. Infants, 2,000 grams and above, were admitted to the study when their bilirubin reached levels specified in the study protocol. All infants under 2,000 grams were admitted. Physical, neurological and mental development of these infants were followed through six years of age. The Biometry and Mathematical Statistics Branch served as a data center for this study and was the focal point for receipt of examination forms. The master files for each year's follow-up were edited for keypunch and coding errors and for internal consistency. The Branch is now analyzing the data in cooperation with the principal investigators from the cooperating units. During this year a study of the control segment of the trial demonstrated that no long-term neurologic toxicity was observed if neonatal bilirubin was not permitted to raise above the level permitted in this study. The results of the newborn data were published in a supplement to Pediatrics in February 1985. Six-year follow-up data was published in Pediatrics, April, 1990. Intelligence at six years in relation to neonatal bilirubin was published in Pediatrics, June, 1991.
