Abstract
Background: We have published results of two randomized, controlled trials comparing lucinactant (Surfaxin®), a new generation, peptide-based synthetic surfactant, with non-protein-containing synthetic colfosceril (Exosurf®) and bovine-derived beractant (Survanta®) (SELECT trial), and with porcine-derived poractant (Curosurf®) (STAR trial) for prevention of respiratory distress syndrome (RDS). In the SELECT trial, Surfaxin significantly reduced the incidence of RDS at 24 h, 14-d RDS-related mortality and bronchopulmonary dysplasia (BPD) at 36 wk post menstrual age (PMA) compared with Exosurf. All-cause mortality at 36 wk PMA and 14-d RDS-related mortality were decreased compared with Survanta. The STAR trial demonstrated similar results for 36-wk mortality without BPD for Surfaxin and Curosurf. Objective: To compare long-term outcomes including mortality and morbidity at 1 year corrected age for Surfaxin vs. synthetic and animal-derived surfactants across the STAR and SELECT trials.
Methods: Infants with gestational age of 24–32 wk and birth weight (BW) of 600-1250 g were randomized to treatment with Surfaxin (175 mg/kg), Exosurf (67.5 mg/kg), Survanta (100 mg/kg), or Curosurf (175 mg/kg). An analysis of outcomes through 1-year corrected age across the two studies was performed for all randomized patients. Treatment differences were compared using the Wilcoxon test, stratified by BW strata, country, gender, and race.
Results: At 1-year corrected age, survival still favored Surfaxin (73.4%) vs. The animal-derived surfactants (71.2%; p=0.05) and Exosurf (69.0%). These observations were consistent with the difference in all-cause mortality at 36 wks PMA for Surfaxin-treated patients (20.3%) vs. The animal-derived products (24.1%; p=0.01), and Exosurf (23.8%). Overall health and gross neurological outcomes trended in favor of Surfaxin over the comparator surfactants.
Conclusion: The early survival advantage observed through 36-wks PMA in premature infants treated with Surfaxin compared with animal-derived surfactants as well as a synthetic, non-protein-containing surfactant was maintained through 1-year corrected age.
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Gadzinowski, J., Moya, F., Sinha, S. et al. 134 Long-Term Outcomes of Lucinactant (Surfaxin) Vs. Animal-Derived and Synthetic, Non–Protein-Containing Synthetic Surfactants in Very Preterm Infants. Pediatr Res 58, 377 (2005). https://doi.org/10.1203/00006450-200508000-00163
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DOI: https://doi.org/10.1203/00006450-200508000-00163
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