A MULTICENTER RANDOMIZED TRIAL COMPARING 2 SURFACTANTS FOR THE TREATMENT OF NEONATAL RESPIRATORY-DISTRESS SYNDROME

Objective: To compare the efficacy of two surfactants, Exosurf Neonata l (Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the t reatment of neonatal respiratory distress syndrome. Design: Multicente r 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: Newb orn infants (n = 617) weighing 501 to 1500 gm with respiratory distres s syndrome who were receiving assisted ventilation with 30% oxygen or more within 6 hours of birth were enrolled between January 1991 and Ja nuary 1992. Interventions: Infants were randomly assigned to receive u p to four intratracheal doses 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 fractio n of inspired oxygen (FIO2) and mean airway pressure (MAP) during the first 72 hours after treatment.