OF INFASURF (CALF LUNG SURFACTANT EXTRACT) TO SURVANTA (BERACTANT) INTHE TREATMENT AND PREVENTION OF RESPIRATORY-DISTRESS SYNDROME

Objective. To compare the relative safety and efficacy of Infasurf (ca lf lung surfactant extract; ONY, Inc, Amherst, NY, IND #27169) versus Survanta (Beractant, Ross Laboratories, Columbus, OH) in reducing the acute severity of respiratory distress syndrome (RDS) when given at bi rth and to infants with established RDS. Design. A prospective, random ized, double-blind, multicenter clinical trial. Setting. Thirteen neon atal intensive care units participated in the treatment arm: seven of these concurrently participated in the prevention arm. Patients. The t reatment arm enrolled infants of less than or equal to 2000 g birth we ight with established RDS, and the prevention arm enrolled infants of less than or equal to 29 weeks' gestation with birth weights <1250 g. Intervention. Infants were randomly assigned to receive Infasurf (n = 303, treatment arm; n = 180, prevention arm) or Survanta (n = 305, tre atment arm; n = 194, prevention arm) in accordance with the Survanta p ackage insert instructions. Outcomes Measures. We projected a 25% redu ction between groups in the need for a third dose of surfactant for in fants with established RDS, and a 25% reduction in the need for a seco nd dose of surfactant for infants who received prophylactic surfactant . Secondary outcomes included the severity of RDS measured by inspired oxygen concentrations and mean airway pressure, air leaks, complicati ons associated with surfactant administration, and survival to 36 week s' postmenstrual age without the need for oxygen supplementation. Resu lts. In the treatment arm, there was no difference between groups in t he number of infants requiring more than two doses of surfactant. The interval between doses was significantly longer for Infasurf, suggesti ng an increased duration of treatment effect. The inspired oxygen conc entration and mean airway pressure were lower in the Infasurf infants during the first 48 hours in the treatment arm. In the prevention arm, there were no differences with respect to the number of surfactant do ses. The dosing intervals were longer for Infasurf infants after the s econd dose. No difference in inspired oxygen or mean airway pressure w as noted during the first 72 hours. There were no significant differen ces in the incidence of air leaks, complications associated with dosin g, complications of prematurity, mortality, or survival without chroni c lung disease in the prevention or treatment arm. Conclusions. Infant s treated with Infasurf have a modest benefit in the acute phase of RD S. Infasurf seems to produce a longer duration of effect than Survanta .