ONE-YEAR FOLLOW-UP OF 89 INFANTS WITH BIRTH WEIGHTS OF 500 TO 749 GRAMS AND RESPIRATORY-DISTRESS SYNDROME RANDOMIZED TO 2 RESCUE DOSES OF SYNTHETIC SURFACTANT OR AIR PLACEBO

Double-blind neurodevelopmental and physical evaluations were conducte d at 1-year adjusted age in 89 infants with birth weights of 500 to 74 9 gm who had respiratory distress syndrome in the neonatal period and were randomized to receive two rescue doses of a synthetic surfactant (Exosurf Neonatal, Burroughs Wellcome Co., Research Triangle Park, N.C .) or air placebo. The trial used a common protocol and was conducted at 13 hospitals; patients were entered in the trial between February 1 988 and September 1990. Ninety-five percent of surviving infants were assessed. Growth and development in the two groups were equivalent, Me an Bayley Scales of Infant Development scores were comparable (mental development index, 79 +/- 22 vs 87 +/- 20; psychomotor development ind ex, 73 +/- 18 vs 81 +/- 19 for air placebo and synthetic surfactant, r espectively). The incidence of severe retinopathy of prematurity was s ignificantly decreased in the surfactant group compared with the air p lacebo group (15% vs 34%; relative risk 0.428; 95% confidence interval 0.2 to 0.9). Overall, administration of surfactant appeared to increa se the probability of a favorable outcome. Confirmation of the trends observed in this study would provide a strong rationale for the rescue use of synthetic surfactant in extremely low birth weight infants wit h respiratory distress syndrome even if overall mortality is not reduc ed.