Double-blind evaluation of developmental and health status to age 2 years of infants weighing 700 to 1350 grams treated prophylactically at birth with a single dose of synthetic surfactant or air placebo.
In a previously published article, we reported results of a two-center study of outcome to 28 days of 385 infants with birth weights from 700 to 1350 gm who were assigned randomly to receive a single 5 ml/kg intratracheal dose of either synthetic surfactant or air placebo. Infants treated with surfactant had a higher rate of survival to 28 days without bronchopulmonary dysplasia than did control subjects given an air placebo. The present study assessed survivors in early childhood to determine neurodevelopmental outcome and late morbidity. Two hundred fifty-eight surviving infants from both centers were evaluated at 1-year adjusted age; medical histories were obtained, standard physical and neurologic examinations were performed, and Bayley Scales of Infant Development were administered. Ophthalmologic examinations were performed at various times between 28 days and 1-year adjusted age. At 2-years adjusted age, 118 infants from one center were reevaluated with the same procedures and also had hearing and speech evaluations. Neither the 1-year assessment of the entire population nor the 2-year assessment of the one center's cohort revealed physical or neurodevelopmental differences between treatment groups. We conclude that administration of a single prophylactic dose of synthetic surfactant to premature infants with birth weights from 700 to 1350 grams results in improved survival rates to 28 days without bronchopulmonary dysplasia and is not associated with adverse health or neurodevelopmental effects at 1-year or 2-years adjusted age.
Kraybill
E N
EN
Department of Pediatrics, University of North Carolina at Chapel Hill 27599-7220, USA.
Bose
C L
CL
Corbet
A J
AJ
Garcia-Prats
J
J
Asbill
D
D
Edwards
K
K
Long
W
W
D000388:Air; D002657:Child Development; D004311:Double-Blind Method; D004338:Drug Combinations; D005233:Fatty Alcohols / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006304:Health Status; D006801:Humans; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D007234:Infant, Premature; D008297:Male; D009422:Nervous System Diseases / Q000453:epidemiology; D009460:Neurologic Examination; D010767:Phosphorylcholine; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011446:Prospective Studies; D011597:Psychomotor Performance; D011663:Pulmonary Surfactants / Q000008:administration & dosage*; 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