EARLY TREATMENT OF RESPIRATORY-DISTRESS SYNDROME WITH BOVINE SURFACTANT IN VERY PRETERM INFANTS - A MULTICENTER CONTROLLED CLINICAL-TRIAL

Objective: To determine the effect of bovine surfactant (SF-RI 1, Alveofact) administered during the first hour following birth to very premature infants [gestational age (GA), 25-30 weeks] in a multicenter, controlled trial. Hypothesis: Survival without bronchopulmonary dysplasia (BPD; definition: ventilator dependency or FiO2 > 0.3 during spontaneous respiration) at day 28 is increased in surfactant-treated infants (sequential analysis). Patients and methods: Thirty-four infants [GA 28.0 +/- 1.5 SD weeks, birth weight (BW), 1,048 +/- 299 g] received 50 mg/kg BW surfactant, whereas 35 infants (GA, 27.6 +/- 1.5 weeks, BW 969 +/- 269 g) served as controls. Retreatment with surfactant (up to three identical doses) 12-24 hours after the previous dose was permitted if FiO2 was > 0.5. Results: Survival without BPD was significantly higher in surfactant treated infants (26/34) compared to controls (14/35; P = 0.003), but in the incidence of pulmonary air leaks, patent ductus arteriosus, intracranial hemorrhage, and nosocomial infections they were not different. Conclusion: Bovine surfactant treatment improves survival without BPD in very premature infants at risk for neonatal respiratory distress syndrome (RDS).