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. American Exosurf Neonatal Study Group I

J Pediatr. 1995 May;126(5 Pt 2):S5-12. doi: 10.1016/s0022-3476(95)70002-1.

Abstract

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 1-year adjusted age. A total of 1046 infants with birth weights from 500 to 1350 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 nerodevelopmental outcomes or impairments. 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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Air
  • Child Development*
  • Double-Blind Method
  • Drug Combinations
  • Fatty Alcohols / therapeutic use
  • Female
  • Follow-Up Studies
  • Humans
  • Infant, Low Birth Weight*
  • Infant, Newborn
  • Infant, Premature*
  • Male
  • Neurologic Examination
  • Phosphorylcholine*
  • Polyethylene Glycols / therapeutic use
  • Prospective Studies
  • Psychomotor Performance
  • Pulmonary Surfactants / chemical synthesis
  • Pulmonary Surfactants / therapeutic use*
  • Respiratory Distress Syndrome, Newborn / prevention & control*
  • Retinopathy of Prematurity / epidemiology

Substances

  • Drug Combinations
  • Fatty Alcohols
  • Pulmonary Surfactants
  • Phosphorylcholine
  • Polyethylene Glycols
  • dipalmitoylphosphatidylcholine, hexadecanol, tyloxapol drug combination