1. Multicenter trial of single-dose modified bovine surfactant extract (Survanta) for prevention of respiratory distress syndrome
- Author
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Soll, Roger F., Hoekstra, Ronald E., Fangman, John J., Corbet, Anthony J., Adams, James M., James, L. Stanley, Schulze, Karl, Oh, William, Roberts, Jesse D., Jr., Dorst, John P., Kramer, Sandra S., Gold, A. Jack, Zola, Elizabeth M., Horbar, Jeffrey D., McAuliffe, Timothy L., and Lucey, Jerold F.
- Subjects
Survanta (Medication) -- Evaluation ,Respiratory distress syndrome -- Drug therapy ,Respiratory distress syndrome -- Prevention ,Pulmonary surfactant -- Health aspects - Abstract
Respiratory distress syndrome (RDS) is a common breathing complication in premature and low-birth-weight infants. It is caused by a deficiency in surfactant, a protein which makes the lungs pliable. When the lungs are inflexible and cannot expand properly, this results in labored breathing and decreased oxygen intake. In an effort to prevent RDS, a natural surfactant can be given to infants at birth. The results of a multicenter trial of single-dose modified bovine surfactant Survanta, a surfactant derived from cows, are reported. Of the 160 low-birth-weight infants (1.7 to 2.8 pounds, or 750 to 1,250 grams) born between 24 and 30 weeks of pregnancy, 79 were treated with Survanta (100 milligrams per kilogram), while 81 were given air without surfactant. All the infants were treated within 37 minutes of birth. The study evaluations, which included chest X-rays, blood gases, inspired oxygen and airway pressure, were assessed over the next 72 hours. The infants receiving Survanta had less severe RDS assessed by chest X-ray findings and improved inspired oxygen than infants receiving no therapy. There was no major difference in the incidence of the most common complications of prematurity, namely necrotizing enterocolitis (tissue death in the intestinal tract), bronchopulmonary dysplasia (development of abnormal lung tissue), pneumothorax (leakage of air from the lungs into the thoracic cavity), intraventricular hemorrhage (bleeding in the spaces of the brain), sepsis (infection) and a patent ductus arteriosus (the maintenance of a connection between the aorta and the pulmonary artery that normally closes after birth). Treated infants had a lower incidence of pneumothorax and an increased incidence of necrotizing enterocolitis. The incidence of all other complications of prematurity were same in the treated and nontreated groups. Survanta therapy improved the inspired oxygen fraction and increased the number of survivors without bronchopulmonary dysplasia in a small subgroup of infants who weighed less than 2.2 pounds (1 kilogram). Although Survanta did not reduce the incidence of RDS complications, it was useful in decreasing the severity of chest X-ray findings and improved oxygenation in the first 72 hours of life. Infants of very low birth weights may benefit the most from Survanta therapy. (Consumer Summary produced by Reliance Medical Information, Inc.)
- Published
- 1990