A comparison of the outcomes of neonates treated with two different natural surfactants.

OBJECTIVE: Our purpose was to determine whether there exists a mortality difference between neonates treated with Infasurf (surfactant A [SA], ONY, Inc, Amherst, NY) and Survanta (surfactant B [SB], Ross Products Division, Abbott Laboratories, Columbus, OH). METHODS: We evaluated 114 different neonatal units' records, between January 1, 2000, and December 31, 2000, of neonates < or = 36 weeks' estimated gestational age who were admitted for neonatal intensive care and reported to have been treated with SA or SB. We used stepwise logistic regression analysis to determine whether the type of surfactant was associated with increased incidence of neonatal death, severe intraventricular hemorrhage, or necrotizing enterocolitis independent of estimated gestational age, birth weight, sex, method of delivery, use of antenatal steroids, or place of birth. RESULTS: We studied the records of 5169 neonates; 1115 (22%) received SA and 4054 (78%) received SB. The most important variables associated with neonatal death, intraventricular hemorrhage and necrotizing enterocolitis were birth weight and estimated gestational age. Logistic regression showed that the type of surfactant did not significantly influence any of these 3 outcomes. Neither overall mortality (8.3% vs 8.5%) or birth weight-specific mortality was different between the 2 groups. CONCLUSION: The differences in mortality previously reported are not present in a larger, more contemporary data set.

A multicenter randomized, masked comparison trial of natural versus synthetic surfactant for the treatment of respiratory distress syndrome.

OBJECTIVE: To compare the efficacy and safety of two surfactant preparations in the treatment of respiratory distress syndrome (RDS). METHODS: We conducted a randomized, masked comparison trial at 21 centers. Infants with RDS who were undergoing mechanical ventilation were eligible for treatment with two doses of either a synthetic (Exosurf) or natural (Infasurf) surfactant if the ratio of arterial to alveolar partial pressure of oxygen was less than or equal to 0.22. Crossover treatment was allowed within 96 hours of age if severe respiratory failure (defined as two consecutive arterial/alveolar oxygen tension ratios < or = 0.10) persisted after two doses of the randomly assigned surfactant. Four primary outcome measures of efficacy (the incidence of pulmonary air leak (< or = 7 days); the severity of RDS; the incidence of death from RDS; and the incidence of survival without bronchopulmonary dysplasia (BPD) at 28 days after birth) were compared by means of linear regression techniques. RESULTS: The primary analysis of efficacy was performed in 1033 eligible infants and an analysis of safety outcomes in the 1126 infants who received study surfactant. Preentry demographic characteristics and respiratory status were similar for the two treatment groups, except for a small but significant difference in mean gestational age (0.5 week) that favored the infasurf treatment group. Pulmonary air leak (< or = 7 days) occurred in 21% of Exosurf- and 11% of infasurf-treated infants (adjusted relative risk, 0.53; 95% confidence interval, 0.40 to 0.71; p < or = 0.0001). During the 72 hours after the initial surfactant treatment, the average fraction of inspired oxygen (+/-SEM) was 0.47 +/- 0.01 for Exosurf- and 0.39 +/- 0.01 for infasurf-treated infants (difference, 0.08; 95% confidence interval, 0.06 to 0.10; p < 0.0001); the average mean airway pressure (+/-SEM) was 8.6 +/- 0.1 cm H2O; for Exosurf- and 7.2 +/- 0.1 cm H2O for Infasurf-treated infants (difference, 1.4 cm H2O; 95% confidence interval, 1.0 to 1.8 cm H2O; p < 0.0001). The incidences of RDS-related death, total respiratory death, death to discharge, and survival without bronchopulmonary dysplasia at 28 days after birth did not differ. The number of days of more than 30% inspired oxygen and of assisted ventilation, but not the duration of hospitalization, were significantly lower in Infasurf-treated infants. CONCLUSION: Compared with Exosurf, Infasurf provided more effective therapy for RDS as assessed by significant reductions in the severity of respiratory disease and in the incidence of air leak complications.