ONE-YEAR OUTCOME IN 232 PREMATURE-INFANTS WITH BIRTH WEIGHTS OF 750 TO 1249 GRAMS AND RESPIRATORY-DISTRESS SYNDROME RANDOMIZED TO RESCUE TREATMENT WITH 2 DOSES OF SYNTHETIC SURFACTANT OR AIR PLACEBO

A randomized, double-blind, placebo-controlled trial was performed in 13 hospitals in Canada to assess whether two rescue doses of a synthet ic surfactant (Exosurf Neonatal) would reduce mortality and morbidity rates in neonates with respiratory distress syndrome who weighed from 750 to 1249 gm. As part of the original trial design, double-blind fol low-up evaluations were performed at 1-year adjusted age. A total of 1 18 patients who received air placebo and 114 patients who received syn thetic surfactant were evaluated at 1 year, Growth and development in the two groups were equivalent. Scores on the Bayley Scales of Infant Development were within the normal range for both groups (mental devel opment index, 90 +/- 22 vs 92 +/- 22; psychomotor development index, 8 1 +/- 19 vs 87 +/- 22 for the air placebo and synthetic surfactant gro ups, respectively), However, in both groups the proportion of infants with any impairment (air placebo group, 43 of 118 (36%); synthetic sur factant group, 41 of 114 (36%)) and severe impairment (air placebo gro up, 29 of 118 [25%]; synthetic surfactant group, 21 of 114 (18%)) was substantial. We conclude that two rescue doses of synthetic surfactant in infants with RDS who weighed 750 to 1249 gm had no detrimental eff ect on developmental outcome or late morbidity. No long-term benefits to 12-months corrected age were observed with the use of surfactant in this weight class. Larger studies or meta-analyses of existing trials will be required to determine if there are any late outcome advantage s associated with rescue use of synthetic surfactant in infants weighi ng 700 to 1249 gm.