DOUBLE-BLIND 1-YEAR FOLLOW-UP OF 1540 INFANTS WITH RESPIRATORY-DISTRESS SYNDROME RANDOMIZED TO RESCUE TREATMENT WITH 2 DOSES OF SYNTHETIC SURFACTANT OR AIR IN 4 CLINICAL-TRIALS

Synthetic surfactant has been shown to reduce neonatal and 1-year mort ality and neonatal morbidity in infants with respiratory distress synd rome, However, less is known about the effects of synthetic surfactant on developmental outcome and long-term morbidity. Four multicenter, r andomized, placebo-controlled trials of synthetic surfactant administe red as rescue therapy were conducted in the United States and Canada, with a total enrollment of 2224 patients. Double-blind developmental e valuations of survivors were conducted at 1 year of age (adjusted for prematurity) in all four trials, Of the 1802 patients enrolled in the placebo-controlled rescue trials who survived to 1 year, 1540 (85%) co mpleted the 1-year follow-up evaluation, Height, weight, and head circ umference measurements were not different in the treatment and control groups, Mean and median Bayley Scores of Infant Development for both the Mental Development Index and the Psychomotor Development Index wer e also equivalent. The incidence of impairments was not different in t he two groups (mild to moderate impairment, 12% [92 of 745] for the ai r placebo group vs 11% [86 of 771] for the synthetic surfactant group; severe impairment, 15% (114 of 745) for the air placebo group vs 13% [102 of 771] for the synthetic surfactant group), No differences in ra tes of retinopathy of prematurity or hearing impairment were found in the treatment groups. The need for surgery after day 28 of life (relat ive risk, 0.779; 95% confidence interval, 0.665, 0.927) and the need f or respiratory support at 1 year (relative risk, 0.525; 95% confidence intervals, 0.303, 0.911) were both reduced in the synthetic surfactan t group, These results indicate that developmental outcome at 1 year o f age is at least as good among infants with respiratory distress synd rome who received rescue therapy with synthetic surfactant as it is in infants who received air placebo; the results also indicate that the incidence of long-term morbidity is reduced.