Double-blind controlled trial of single-dose treatment with bovine surfactant in severe hyaline membrane disease.

In a double-blind clinical trial the effects of a single dose of reconstituted bovine surfactant ('Surfactant TA') were assessed in 30 premature infants (birthweight 751-1750 g) with severe hyaline membrane disease. 17 infants had a sonicated saline suspension of 100 mg/kg surfactant phospholipid instilled into the trachea at 5.0 (SD 0.7) hours of age and 13 infants received saline by the same route at 4.3 (1.1) hours of age. In the surfactant-treated group there was early improvement in oxygenation and ventilation. Haemodynamically significant patent ductus arteriosus occurred more often in the surfactant group; pneumothorax and pulmonary interstitial emphysema occurred less often. The combined incidence of death and severe bronchopulmonary dysplasia was significantly lower in the surfactant group (3/17) than in the placebo group (9/13).