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.
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.
Corbet
A
A
Department of Pediatrics, Baylor College of Medicine, Houston, Texas, USA.
Long
W
W
Schumacher
R
R
Gerdes
J
J
Cotton
R
R
D000388:Air; D002657:Child Development; D004311:Double-Blind Method; D004338:Drug Combinations; D005233:Fatty Alcohols / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D007234:Infant, Premature; D008297:Male; D009460:Neurologic Examination; D010767:Phosphorylcholine; D011092:Polyethylene Glycols / Q000627:therapeutic use; D011446:Prospective Studies; D011597:Psychomotor Performance; D011663:Pulmonary Surfactants / Q000138:chemical synthesis / Q000627:therapeutic use*; D012127:Respiratory Distress Syndrome, Newborn / Q000517:prevention & control*; D012178:Retinopathy of Prematurity / Q000453:epidemiology
D004338:Drug Combinations; D005233:Fatty Alcohols; D011663:Pulmonary Surfactants; D010767:Phosphorylcholine; D011092:Polyethylene Glycols; C047049:dipalmitoylphosphatidylcholine, hexadecanol, tyloxapol drug combination