PEDIATRICS Vol. 76 No. 4 October 1985, pp. 585-592
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Double-Blind Clinical Trial of Calf Lung Surfactant Extract for the Prevention of Hyaline Membrane Disease in Extremely Premature Infants

Melinda S. Kwong MD1, Edmund A. Egan MD1, Robert H. Notter MD, PhD1, and Donald L. Shapiro MD1

1 From the Departments of Pediatrics, University at Buffalo, State University of New York, Children's Hospital, Buffalo; and University of Rochester School of Medicine, Rochester, New York

A prospective, double-blind, controlled trial was conducted to determine whether instillation of an exogenous surfactant into the lungs before the first breath could prevent hyaline membrane disease. The surfactant is calf lung lipid extracted from saline lung lavage. Entry was limited to infants who were 24 to 28 weeks' gestation, who were born at Children's Hospital of Buffalo, and whose mothers had not received betamethasone for more than 24 hours before birth. Treated infants received 3 mL (90 mg) of calf lung surfactant extract instilled into their trachea before the first breath; control infants received 3 mL of normal saline. A prospective scoring system and respiratory support variables were used to compare the groups. At 48 hours of age, only two of 14 calf lung surfactant extract-treated infants (14%) had hyaline membrane disease compared with seven of 13 control infants (54%) (P = .033). Inspired oxygen, mean airway pressure, ventilator rate and ventilator efficiency index were also lower in the treated group during the first 48 hours of life (P < .01 to P < .001). Calf lung surfactant extract instillation at birth appears to be an effective material and method of preventing hyaline membrane disease in extremely premature infants.

Key Words: hyaline membrane disease • surfactant replacement • controlled trial

Submitted on April 26, 1985
Accepted on June 13, 1985




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