PEDIATRICS Vol. 79 No. 1 January 1987, pp. 31-37
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Randomized Controlled Trial of Exogenous Surfactant for the Treatment of Hyaline Membrane Disease

Jonathan D. Gitlin MD1, Roger F. Soll MD1, Richard B. Parad MD1, Jeffrey D. Horbar MD1, Henry A. Feldman PhD1, Jerold F. Lucey MD1, and H. William Taeusch MD1

1 From the Departments of Pediatrics and Biostatistics, Harvard School of Public Health, Boston, and the Department of Pediatrics, University of Vermont College of Medicine, Burlington

We conducted a prospective, randomized, unblinded, controlled trial of exogenous bovine surfactant (surfactant TA) in premature infants requiring ventilator support for the treatment of severe hyaline membrane disease. Forty-one low birth weight infants with severe hyaline membrane disease were randomly assigned to saline or surfactant therapy and treated within eight hours of birth. Significant improvements in oxygenation (increased arterial/alveolar Po2) and respiratory support (decreased mean airway pressure) were seen in the group receiving surfactant within four hours after treatment. These improvements were maintained in the surfactant-treated infants, who also had fewer pneumothoraces and fewer number of days in environments of fractional inspiratory oxygen greater than 0.4 mm Hg. No problems were associated with administration of surfactant, and no acute side effects were detected. We conclude that exogenous surfactant, administered early in the course of severe hyaline membrane disease, is an effective therapy that can diminish the amount of respiratory support required during the first 48 hours of life.

Key Words: TA surfactant • hyaline membrane disease

Submitted on April 16, 1986




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