ONE-YEAR FOLLOW-UP EVALUATION OF 260 PREMATURE-INFANTS WITH RESPIRATORY-DISTRESS SYNDROME AND BIRTH WEIGHTS OF 700 TO 1350 GRAMS RANDOMIZEDTO 2 RESCUE DOSES OF SYNTHETIC SURFACTANT OR AIR PLACEBO

A multicenter, randomized, double-blind, placebo-controlled trial of s ynthetic surfactant therapy for premature infants with respiratory dis tress syndrome (RDS) and birth weights of 700 to 1350 gm demonstrated a reduction in severity of RDS, morbidity, and neonatol and 1-year mor tality, Of the 419 infants who were entered in the study, 80% of the s urviving infants in both the air placebo group (122) and the synthetic surfactant group (138) returned for the follow-up evaluation at 1-yea r adjusted age. The only significant difference observed at follow-up was a reduction in the incidence of mild cerebral palsy in the synthet ic surfactant group (air placebo group, 8 of 122 (7%); synthetic surfa ctant group, 3 of 138 (2%); relative risk 0.306; 95% confidence interv al 0.094, 0.999), No differences were observed between the air placebo and synthetic surfactant treatment groups with respect to health stat us of the infants, including the incidence of retinopathy of prematuri ty and neurodevelopmental delays, The difference in the overall incide nce of impairment among the 1-year survivors in the air placebo group (43 of 122 (35%)) and in the synthetic surfactant group (40 of 138 (29 %)) was not statistically significant. The results of this 1-year foll ow-up study show that rescue treatment with synthetic surfactant in in fants weighing 700 to 1300 gm is not associated with adverse developme ntal consequences despite the improvement in survival.