Surfactant replacement therapy in neonatal respiratory distress syndrome. A multi-centre, randomized clinical trial: comparison of high- versus low-dose of surfactant TA.

We conducted a prospective, randomized, controlled trial comparing the efficacy of two doses of a reconstituted bovine surfactant (Surfactant TA) in premature infants requiring mechanical ventilation shortly after birth for respiratory distress syndrome. Forty-six infants weighting 1000-1499 g were randomized into two groups: a low-dose group (23 infants given a single dose of 60 mg surfactant lipid/kg) and a high-dose group (23 infants given a single dose of 120 mg/kg). The mean (SD) age at which surfactant was given was 5.5 (+/- 1.2) h in the low-dose group and 6.0 (+/- 1.5) h in the high dose group. Both treatments improved oxygenation (increased arterial-alveolar PO2 ratio) with decreased mean airway pressure, the high-dose surfactant having a more beneficial effect in prolonging the response. Infants in the high-dose group had significantly less (P less than 0.05) incidence of both intraventricular haemorrhage and bronchopulmonary dysplasia. This prospective trial documents that a greater benefit can be obtained by increasing the dose of surfactant (120 mg/kg) beyond 60 mg/kg treatment of premature infants with severe respiratory distress syndrome (RDS).