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

The efficacy of a natural porcine surfactant and a synthetic surfactant wer e compared in a randomized trial. In three neonatal intensive care units, 2 28 neonates with respiratory distress and a ratio of arterial to alveolar p artial pressure of oxygen <0.22 were randomly assigned to receive either Cu rosurf 100 mg kg(-1) or Exosurf Neonatal 5 ml kg(-1) After Curosurf, the fr action of inspired oxygen was lower from 15 min (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 t he mean airway pressure was lower at 1 h (8.3 +/- 3.2 mmH(2)O vs 9.4 +/- 3. 1 mmH(2)O, p = 0.01). Thereafter the respiratory parameters were similar. T he 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 Exo surf. After Curosurf C-reactive protein value over 40 mg l(-1) 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, p = 0.001) and bacteraemia in 11% (vs 4%; RR 3 .17, 95%CI 1.05-9.52, p < 0.05). We conclude that when given as rescue therapy Curosurf had no advantage com pared with Exosurf in addition to the more effective initial response. Curo surf may increase the risk of infection.