Surfactant Comparison Trial

Purpose
To compare the efficacy of a synthetic surfactant (Exosurf Neonatal, Burroughs-Wellcome Co) and a modified bovine surfactant extract (Survanta, Ross Laboratories) in the treatment of neonatal respiratory distress syndrome (RDS)

Study Design
Multicenter, randomized trial at 38 neonatal intensive care units in the Vermont Oxford Network

Methods
Premature infants (n = 1296) weighing 501 to 1500 g with RDS requiring assisted ventilation with 30% oxygen or more were enrolled within 6 hours of birth. Infants were randomly assigned to receive up to four intratracheal doses of the synthetic surfactant (Exosurf Neonatal, n = 644) or the modified bovine surfactant extract (Survanta, n = 652).

Primary Outcome
Death or chronic 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 lower risk of chronic lung disease or death at 28 days (Survanta, 27% vs Exosurf, 34%; RR, 0.78; 95% CI, 0.60 to 0.99). Treatment with Survanta led to significant improvement in several secondary outcome measures. Survanta-treated infants received less supplemental oxygen and had lower mean airway pressure 6 and 72 hours after treatment. Survanta-treated infants had significantly fewer pneumothoraces (Survanta, 9% vs Exosurf, 15%; RR, 0.60; 95% CI, 0.44 to 0.81). There were no differences 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 chronic lung disease at 28 days of age, the significant improvement in secondary clinical outcomes suggests that Survanta is more effective than Exosurf Neonatal in the treatment of established RDS.

Publication
Vermont-Oxford Neonatal Network. A multicenter, randomized trial comparing synthetic surfactant With modified bovine surfactant extract in the treatment of neonatal respiratory distress syndrome. Pediatrics. 1996;97(1): 1-6. PubMed: 8545199

Sponsor
McDonald’s Award for Excellence