DOUBLE-BLIND DEVELOPMENTAL EVALUATION AT 1-YEAR CORRECTED AGE OF 597 PREMATURE-INFANTS WITH BIRTH WEIGHTS FROM 500 TO 1350 GRAMS ENROLLED IN 3 PLACEBO-CONTROLLED TRIALS OF PROPHYLACTIC SYNTHETIC SURFACTANT
A. Corbet et al., DOUBLE-BLIND DEVELOPMENTAL EVALUATION AT 1-YEAR CORRECTED AGE OF 597 PREMATURE-INFANTS WITH BIRTH WEIGHTS FROM 500 TO 1350 GRAMS ENROLLED IN 3 PLACEBO-CONTROLLED TRIALS OF PROPHYLACTIC SYNTHETIC SURFACTANT, The Journal of pediatrics, 126(5), 1995, pp. 5-12
Infants enrolled in three clinical trials of prophylactic treatment fo
r respiratory distress syndrome with a single dose of synthetic surfac
tant (Exosurf Neonatal) or air placebo were monitored through 1-year a
djusted age, A total of 1046 infants with birth weights from 500 to 43
50 gm were enrolled in the three trials; of the 735 infants who surviv
ed to 1 year of age, follow-up evaluations were completed for 597 (80%
, air placebo group; 82%, synthetic surfactant group), Infants in the
air placebo and synthetic surfactant treatment groups had no differenc
es in general health, growth, or neurodevelopmental outcomes or impair
ments, These follow-up results at 1-year adjusted age for infants who
received a single dose of synthetic surfactant indicate that a single
dose of synthetic surfactant reduces mortality without increasing the
absolute number or proportion of infants with impairments at 1 year of
age.