Double-blind developmental evaluation at 1-year corrected age of 597 premature infants with birth weights from 500 to 1350 grams enrolled in three placebo-controlled trials of prophylactic synthetic surfactant
Corbet, A.; Long, W.; Schumacher, R.; Gerdes, J.; Cotton, R.; Group, A.E.osurf Neonatal Study
Journal of Pediatrics 126(5 Part 2): S5-S12
ISSN/ISBN: 0022-3476 DOI: 10.1016/s0022-3476(95)70002-1
Infants enrolled in three clinical trials of prophylactic treatment for respiratory distress syndrome with a single dose of synthetic surfactant (Exosurf Neonatal) or air placebo were monitored through 4-year adjusted age. A total of 4046 infants with birth weights from 500 to 4350 gm were enrolled in the three trials; of the 735 infants who survived 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 differences in general health, growth, or neurodevelopmental outcomes or impairments. These follow-up results at 4-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 4 year of age.