Pumactant and poractant alfa for treatment of respiratory distress syndrome in neonates born at 25-29 weeks' gestation: a randomised trial

Background Exogenous surfactant preparations vary in their constitution and biophysical properties. Synthetic and animal-derived preparations lower th e rate of death compared with controls. No significant differences in morta lity or important long-term clinical outcomes have been shown between them in randomised trials, We did a randomised controlled trial to compare pumac tant, a synthetic surfactant, with poractant alfa, an animal-derived surfac tant, both of which are widely used in the UK. Methods We enrolled 212 neonates born between 25 weeks' and 29 weeks and 6 days' gestation who were intubated for presumed surfactant deficiency and w ere free from life-threatening malformations, We randomly assigned 105 neon ates poractant alfa, and 107 pumactant. The primary outcome was duration of high-dependency care and mortality was a secondary outcome. Analysis was b y intention to treat. Findings Outcome data were analysed for 199 babies. The trial was stopped o n the recommendation of the data and safety monitoring committee because mo rtality assumed a greater importance than the primary outcome, Predischarge mortality differed significantly between groups, in favour of poractant al fa (14.1 vs 31.0%, p=0.006; odds ratio 0.37 [95% CI 0.18-0.76). This differ ence was sustained after adjustment for centre, gestation, birthweight, sex , plurality, and use of antenatal steroids, Interpretation Mortality was unexpectedly lower among neonates who received poractant alfa than among those who received pumactant, and was independen t of all the variables we investigated. Stopping the trial early may have w idened the difference between the treatment groups.