Randomized trial comparing natural and synthetic surfactant: increased infection rate after natural surfactant?

Abstract

The efficacy of a natural porcine surfactant and a synthetic surfactant were compared in a randomized trial. In three neonatal intensive care units, 228 neonates with respiratory distress and a ratio of arterial to alveolar partial pressure of oxygen <0.22 were randomly assigned to receive either Curosurf 100mgkg−1 or Exosurf Neonatal 5 ml kg−1. After Curosurf, the fraction of inspired oxygen was lower from 15min (0.45 ± 0.22 vs 0.70 ± 0.22, p = 0.0001) to 6 h (0.48 ± 0.26 vs 0.64 ± 0.23,p= 0.0001) and the mean airway pressure was lower at 1 h (8.3 3.2 mmH2O vs 9.4 ± 3.1 mmH2O β= 0.01). Thereafter the respiratory parameters were similar. The duration of mechanical ventilation (median 6 vs 5 d) and the duration of oxygen supplementation (median 5 vs 4 d) were similar for Curosurf and Exosurf After Curosurf, C‐reactive protein value over 40 mg r1 occurred in 45% (vs 12%; RR 3.62, 95%CI 2.12‐6.17, p = 0.001), leukopenia in 52% (vs 28%; RR 1.85, 95%CI 1.31‐2.61, β= 0.001) and bacteraemia in 11% (vs 4%; RR3.17, 95%CI 1.05‐9.52, p < 0.05).We conclude that when given as rescue therapy Curosurf had no advantage compared with Exosurf in addition to the more effective initial response. Curosurf may increase the risk of infection.