[Treatment of severe meconium aspiration syndrome with porcine lung-derived surfactant: a multicenter, randomized, controlled trial].

OBJECTIVE

A randomized controlled clinical trial was performed in nineteen Chinese neonatal intensive care units to evaluate the safety and efficacy of exogenous surfactant replacement therapy for severe meconium aspiration syndrome (MAS) in term and near-term neonates.

METHODS

During the period from March 22, 2001 to April 4, 2003, 61 term infants with severe MAS were randomly assigned to either a surfactant or a control group within 36 h after birth. The infants in the surfactant group (n = 31) received an initial dose of porcine lung-derived surfactant (Curosurf) at 200 mg/kg, and repeated doses of 200, 100 and 100 mg/kg were given at 6 - 12 h intervals to a maximum of four doses if oxygenation index (OI) deteriorated by > 2 from baseline. The primary outcomes were a reduction of OI to less than 10 and an increase of the pre-treatment a/A PO2 ratio of 100% over baseline 24 h after surfactant treatment. The secondary outcomes were duration of mechanical ventilation, occurrence of complications and survival to discharge from hospital.

RESULTS

The general demographic characteristics of the study subjects between the 2 groups were similar. There was a trend for surfactant-treated infants to have an improvement in arterial oxygenation compared to the control group. In comparison with the control group at 24 h, the surfactant group had a lower mean OI (8.1 vs. 10.9), more infants with a 100% increase of a/A PO2 (83% vs. 48%, P < 0.01) over baseline, and a larger area under the curve for PaO2/FiO2 over baseline [(3762 +/- 1877) vs. (2715 +/- 1644) mm Hg x h (P < 0.05, 1 mm Hg = 0.133 kPa)]. Repeated measures of these parameters were also in favor of surfactant group during 24 h to 3 and 7 days compared to the baseline (P < 0.05). No significant differences were found in mean duration of mechanical ventilation (105 +/- 81 vs. 80 +/- 40), occurrence of major complications and survival rate (96.8% vs. 90.0%) between the surfactant and the control groups.

CONCLUSION

Surfactant replacement therapy improved oxygenation but did not increase complications in the study subjects, suggesting that surfactant may be effective and safe for treatment of severe MAS in term and near-term infants.