Bronchoalveolar Lavage with Dilute Surfaxin™ (KL4-Surfactant) for the Management of the Meconium Aspiration Syndrome (MAS)

Abstract 1926 Poster Session IV, Tuesday, 5/4 (poster 341)

Background: Infants with MAS have marked surfactant dysfunction. Alveoli of affected neonates contain meconium, inflammatory cells, inflammatory mediators, edema fluid, protein, and other debris. Recent work in animal models of MAS suggests benefit using lung lavage with dilute Surfaxin™ ( PEDIATR RES 1998;44:705-715). We performed a controlled trial to assess this therapy in newborn infants with MAS. Methods: Inclusion criteria were: 1) GA ≥ 35 weeks; 2) enrollment within 72 hours of birth; 3) diagnosis of MAS; 4) need for mechanical ventilation; and 5) an oxygenation index (OI) ≥ 8 and ≤ 25. Subjects were randomized to either lavage with Surfaxin™ or standard of care (2:1 proportion). In lavaged infants, a volume of 8 mL/kg of dilute Surfaxin™ (2.5 mg/mL) was instilled into each lung followed by suctioning after 5 breaths. The procedure was repeated twice. The third instillation was with a more concentrated solution (10 mg/mL). Results: 22 infants were enrolled (15 Surfaxin™ and 7 control). Demographic characteristics were similar. Surfaxin™-lavaged infants were weaned from mechanical ventilation earlier (mean 6.3 vs. 9.9 days, respectively) and had lower oxygenation indexes compared to control infants (Figure). Conclusion: Dilute Surfaxin™ lavage appears to be an effective therapy in the treatment of MAS. Further studies are needed to define the best management strategies using Surfaxin™.

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*This investigation was funded by Discovery Laboratories, Inc., Doylestown, PA

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