OVERVIEW OF CLINICAL-TRIALS COMPARING NATURAL AND SYNTHETIC SURFACTANTS

This overview summarizes the ten randomized clinical trials that have compared different surfactant preparations. Six trials, enrolling 2,45 0 babies with respiratory distress syndrome (RDS), compared Survanta a nd Exosurf Babies treated with the natural surfactant had lower oxygen requirements for at least 3 days than those treated with the syntheti c surfactant. The babies treated with Survanta had lower risks of neon atal mortality (odds ratio, OR, 0.80; 95% confidence interal, CI, 0.65 -1.00), retinopathy of prematurity (OR 0.68; 95% CI 0.50-0.94), and de ath or bronchopulmonary dysplasia (OR 0.84; 95% CI 0.70-1.00) when com pared to those treated with Exosurf. Infasurf has been compared with E xosurf in two studies: one as prophylaxis and the other a rescue trial . Similar, although non-significant benefits were found for the natura l surfactant. When all eight trials were included in a metaanalysis, t here was a significant reduction in the odds of pulmonary air leaks (O R 0.52; 95% CI 0.41-0.66) for babies treated with natural as compared with synthetic surfactants. For seven trials (3,576 babies) comparing natural and synthetic surfactants to treat RDS (six comparing Survanta and Exosurf and one Infasurf and Exosurf), there was a significantly reduced risk of neonatal mortality (OR 0.80; 95% CI 0.66-0.97) with na tural as compared with synthetic surfactant treatment. In two further trials different natural surfactant preparations have been compared. R educed oxygen needs for 24 h after treatment were found for Infasurf a nd Curosurf, respectively, when compared to Survanta. Apparent longer- term benefits from these surfactants were not statistically significan t. Further trials are needed to be certain of the differences between various surfactant preparations.