Effects of the early administration of sivelestat sodium on bronchopulmonary dysplasia in infants: A retrospective cohort study

Abstract Background Chorioamnionitis, or infiltration of the chorioamnion by neutrophils, is a risk factor associated with the development of bronchopulmonary dysplasia. Increased neutrophil elastase levels are observed in the tracheal aspirates of these patients. Aims To examine the effects of early administration of the selective neutrophil elastase inhibitor sivelestat, which is used to treat acute lung injury in adults, on bronchopulmonary dysplasia in extremely premature infants. Study design Retrospective cohort study. Subjects This study included extremely low-birth-weight infants born at a gestational age  Outcome measures The primary outcome was the rate of bronchopulmonary dysplasia-free survival at a postmenstrual age of 36 weeks, and the secondary outcomes included various clinically significant factors of neonatal mortality and morbidity and adverse events. Results Of the 1031 included neonates, 124 (12.0%) were treated with sivelestat. Significant differences between the groups were noted for gestational age, delivery method, fetal number, the frequency of chorioamnionitis, immunoglobulin M levels, and WBC counts. No differences were identified concerning the bronchopulmonary dysplasia-free survival rate at a postmenstrual age of 36 weeks (adjusted odds ratio for sivelestat to control, 0.83; 95% confidence interval = 0.53–1.30). Secondary outcomes did not significantly differ between the groups. Conclusions In extremely premature infants, early sivelestat use was not associated with an improved rate of survival without bronchopulmonary dysplasia at a postmenstrual age of 36 weeks.