Observational study to compare the clinical efficacy of the natural surfactants Alveofact and Curosurf in the treatment of respiratory distress syndrome in premature infants

SummaryIntroductionNatural surfactants have been shown to be superior to synthetic surfactants in the treatment of neonatal respiratory distress syndrome (RDS). In Germany, Alveofact® (A) and Curosurf® (C) are the most frequently used natural surfactant preparations. The aim of this retrospective, observational study was to compare the effects of A and C on gas exchange and outcome in premature infants.MethodsDuring a 5-year period in our neonatal intensive care unit (NICU), 187 premature infants were treated with surfactant, with 82 receiving A and 105 receiving C. We recorded FIO2 and gas exchange (PaO2/FIO2 ratio, PaCO2, SaO2) during the first 72 h after surfactant application and the incidence of outcome parameters at day 28 (bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH grade III or IV), patent ductus arteriosus (PDA), pneumothorax, necrotizing enterocolites (NEC) and death). The differences between the patient groups were assessed by ANOVA or the calculation of relative risks. Bonferroni correction was used for multiple comparisons.ResultsThere were no statistically significant differences between infants treated with A and C in mean gestational age (28.4 vs. 28.4 weeks), birth weight (1210 vs.1258 g) and time of first surfactant application (60 vs. 90 min postnatal). We observed no significant between group differences in course of FIO2 and blood gases, or in incidence at day 28 of BPD (41.7% vs. 42.8%), IVH III/IV (18.3% vs. 14.3%), pneumothorax (9.8% vs. 4.8%), PDA (23.2% vs. 21.9%), PVL (7.3% vs. 9.5%) and death (17% vs. 17.1%). There were also no statistically significant differences in the subgroup of infants <28 weeks. The lower incidence of NEC in A compared with C (1.2% vs. 10.5%, P=0.01P=0.01) was not statistically significant after Bonferroni correction.ConclusionIndependent of gestational age no significant difference in the clinical efficacy of A and C was observed.