A MULTICENTER, RANDOMIZED TRIAL COMPARING SYNTHETIC SURFACTANT WITH MODIFIED BOVINE SURFACTANT EXTRACT IN THE TREATMENT OF NEONATAL RESPIRATORY-DISTRESS SYNDROME

Objective. To compare the efficacy of a synthetic surfactant (Exosurf Neonatal, Burroughs-Wellcome Co) and a modified bovine surfactant extr act (Survanta, Ross Laboratories) in the treatment of neonatal respira tory distress syndrome (RDS). Design. Multicenter, randomized trial. S etting. Thirty-eight neonatal intensive fare units participating in th e Vermont-Oxford Neonatal Network. Patients. Premature infants (n = 12 96) weighing 501 to 1500 g with RDS requiring assisted ventilation wit h 30% oxygen or more were enrolled within 6 hours of birth. Interventi ons. Infants were randomly assigned to receive up to four intratrachea l doses of the synthetic surfactant (Exosurf Neonatal, n = 644) or the modified bovine surfactant extract (Survanta, n = 652). Main Outcome Measure. The primary outcome measure was the occurrence of death or ch ronic lung disease 28 days after birth. Results. Death or chronic lung disease occurred in 57% of the infants treated with Exosurf Neonatal and in 54% of those infants treated with Survanta (relative risk [RR], 0.95; 95% confidence interval [CI], 0.86 to 1.04). Infants with birth weights of 1001 to 1500 g who received Survanta had a significantly l ower risk of chronic lung disease or death at 28 days (Survanta, 27% v s Exosurf, 34%; RR, 0.78; 95% CI, 0.60 to 0.99). Treatment with Survan ta led to significant improvement in several secondary outcome measure s. Survanta-treated infants received less supplemental oxygen and had lower mean airway pressure 6 and 72 hours after treatment. Survanta-tr eated infants had significantly fewer pneumothoraces (Survanta, 9% vs Exosurf, 15%; RR, 0.60; 95% CI, 0.44 to 0.81). There were no differenc es between the groups in the incidence of other neonatal complications . Conclusion. Although no differences were noted between Survanta- and Exosurf-treated infants regarding the primary outcome of death or chr onic lung disease at 28 days of age, the significant improvement in se condary clinical outcomes suggests that Survanta is more effective tha n Exosurf Neonatal in the treatment of established RDS.