A multicenter randomized trial comparing two surfactants for the treatment of neonatal respiratory distress syndrome

Objective : To compare the efficacy of two surfactants, Exosurf Neonatal(Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the treatment of neonatal respiratory distress syndrome. Design : Multicenter randomized trial. Setting : Eleven tertiary care university neonatal intensive care units participating in the National Institute of Child Health and Human Development Neonatal Research Network. Patients : Newborn infants (n=617) weighing 501 to 1500 gm with respiratory distresssyndrome who were receiving assisted ventilation with 30% oxygen or more within 6 hours of birth were enrolled between January 1991 and January 1992. Interventions : Infants were randomly assigned to receive up to four intratrachealdoses of either Exosurf Neonatal (n=309) or Survanta (n=308). Main outcome measures : The occurrence of death or bronchopulmonary dysplasia 28 days after birth and the average fraction of inspired oxygen (Fio 2 ) and mean airway pressure (MAP) during the first 72 hours after treatment. Results : Death or bronchopulmonary dysplasia occurred in 67% of the infants in the Exosurf group and 62% of those in the Survanta group (adjusted relative risk, 1.07; 95% confidence interval, 0.96 to 1.20). During the 72 hours after the first surfactant dose, the average Fio 2 (±SEM) was 0.50±0.01 for Exosurf and 0.42±0.01 for Survanta (difference, 0.08; 95% confidence interval, 0.05 to 0.11); the average MAP (±SEM) was 7.64±0.21 cm H 2 O for Exosurf and 6.93±0.21 cm H 2 O for Survanta (difference, 0.71 cm H 2 O; 95% confidence interval, 0.13 to 1.29 cm H 2 O). There was no difference between the groups in the incidence of other neonatal morbidities or in the duration of hospitalization, assisted ventilation, or supplemental oxygen administration. Conclusion : We found no difference between treatment groups in the incidence of death or bronchopulmonary dysplasia, although we did observe a difference in the initial response to treatment as measured by Fio 2 and MAP.