PEDIATRICS Vol. 82 No. 5 November 1988, pp. 756-762
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Surfactant Replacement Therapy at Birth: Final Analysis of a Clinical Trial and Comparisons With Similar Trials

James W. Kendig MD1, Robert H. Notter MD, PhD1, Christopher Cox PhD1, Judy L. Aschner MD1, Steven Benn MD1, Richard M. Bernstein MD1, Karen Hendricks-Munoz MD1, William M. Maniscalco MD1, Leon A. Metlay MD1, Dale L. Phelps MD1, Robert A. Sinkin MD1, Beverly P. Wood MD1, and Donald L. Shapiro MD1

1 From the Departments of Pediatrics (Neonatology), Radiology, Pathology, and Laboratory Medicine, the Division of Biostatistics, and the Specialized Center of Research in Pulmonary Diseases of Newborns, University of Rochester School of Medicine and Dentistry, Rochester, New York

A randomized trial of surfactant replacement therapy at birth was conducted at the University of Rochester between June 1983 and November 1985. Thirty-four premature infants, 25 to 29 weeks' gestational age, received a preventilatory dose of a calf lung surfactant extract in saline prepared at the University of Rochester. A control group of 31 infants received a preventilatory dose of saline alone. The major finding of this trial is that a single preventilatory dose of calf lung surfactant extract reduces the severity of the respiratory distress syndrome during the first 24 hours of life. The beneficial effects, however, are not sustained in many infants and diminish after 24 hours of life. The survival rate was 71% in both the control and surfactant-treated groups. There was a lower incidence of pneumothorax in the surfactant-treated group. There were no differences in the incidence of bronchopulmonary dysplasia, patent ductus arteriosus, and intraventricular hemorrhage. No adverse effects of surfactant replacement therapy were identified. Results of this study suggest that multiple postventilatory doses of surfactant will be required for optimal therapy.

Key Words: surfactant replacement therapy • respiratory distress syndrome • lung • premature infants

Submitted on January 11, 1988
Accepted on April 18, 1988




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