Abstract
Background: Animal-derived, protein-containing surfactants perform better vs. non–protein-containing surfactants for the prevention and treatment of Respiratory Distress Syndrome (RDS). A new generation, non–animal-derived surfactant, Surfaxin, containing a peptide that mimics human SP-B, appears effective in animals and in early studies of infants with RDS.1 Our objective was to compare the efficacy and safety of Surfaxin vs. Exosurf in the prevention of RDS.
Methods: This was a Phase 3, pivotal, masked, multinational, randomized trial comparing Surfaxin (5.8 mL/kg or 175 mg/kg) vs. Exosurf for preventing RDS. Survanta® served as a reference arm in a 2:2:1 randomization strategy. Exosurf and Survanta were dosed per package insert. Inclusion criteria were: birth weight (BW) 600–1250 g, gestational age (GA) <32 wk, and successful intubation. Dosing occurred within 30 min of birth. Primary outcomes (adjudicated by an independent masked committee) were the incidence of RDS at 24 hours and RDS-related mortality by Day 14. Secondary outcomes included the occurrence of air leaks, incidence of bronchopulmonary dysplasia at the postconceptional ages of 28 days and 36 weeks, and other complications of prematurity. The trial was event-driven; primary outcomes and overall safety were assessed by an independent Data Safety Monitoring Board.
Results: Over 22 months, 49 centers randomized 1294 infants in BW strata of 600– 800 g, 801–1000 g, and 1001–1250 g. Overall BW and GA were 1001 g and 29.3 weeks, respectively. Primary outcome results are shown below: See table.
Conclusion: Surfaxin is significantly more efficacious than Exosurf in the prevention of RDS and in reducing RDS-related mortality through 14 days after birth.
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Moya, F., Gadzinowski, J., Bancalari, E. et al. 194 Superiority of A Novel Surfactant, Surfaxin (Lucinactant), Over Exosurf (Colfosceril Palmitate) in Prevnting Respiratory Distress Syndrome in Very Preterm Infants: A Pivotal, Multinational, Randomized Trial. Pediatr Res 56, 497 (2004). https://doi.org/10.1203/00006450-200409000-00217
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DOI: https://doi.org/10.1203/00006450-200409000-00217