246 A Randomized, Controlled Multicenter Trial Of Porcine Surfactant® For Treatment Of Severe Meconium Aspiration Syndrome

Abstract

Background and objective: Despite improved perinatal monitoring and respiratory care, severe meconium aspiration syndrome (MAS) remains a life threatening respiratory disorder in early postnatal period. Pathogenesis and pathophysiology of MAS involves surfactant dysfunction due to inactivation by meconium at alveolar spaces. There has been no report about efficacy of Curosurf in MAS although a retrospective study revealed certain benefits. We hypothesized that in severe MAS, meconium-induced lung injury and impaired gas exchange may be altered by exogenous surfactant, and conducted this randomized. Controlled, multicenter study. Subjects and methods: Sixty-one term infants with severe MAS within 36 hours after birth were enrolled in this trial in nineteen neonatal intensive care services. The infants in the treatment group (n=31) received an initial dose of Curosurf at 200 mg/kg body weight, and repeated doses were given in 200, 100 and 100 mg/kg if a/A of the infant remained <0.20 at 6–12 hours after the previous dose. The primary evaluated parameters were oxygen requirement, ventilator settings, and incidence of complications. Results: The baseline demographic characteristics of the two groups were similar. There was a trend in favour of Curosurf for a more rapid improvement in blood oxygenation (Figure). The mean oxygenation index (OI) in the Curosurf group was significantly lower than the baseline value starting from the assessment at 1 hour. The number of infants with OI <10 in the Curosurf group was numerically higher than that in the control group (p<0.05 at the assessment of 24 hours post-administration). The a/A ratio at 24 hours was increased >100% compared to baseline in 24/29 (83%) infants treated with Curosurf and in 12/25 (48%) infants in the control group (p<0.05). Other secondary efficacy variables: reduction of MAP by ≥ 2 cm H20 at 24 and 72 hours, duration of mechanical ventilation, cumulative exposure to oxygen, did not show significant differences between groups. The survival rate was 30/31 and 27/30 in the Curosurf and control group, respectively. The incidence of complications did not differ between groups. Conclusion: Surfactant replacement therapy improved oxygenation and did not increase complications in the study subjects, suggesting that surfactant is effective and safe for treatment of severe MAS in term infants.