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Treating premature infants with alpha1-proteinase inhibitor (A1PI) may hinder the evolution of chronic lung disease (CLD) and reduce the risk of bleeding in the lungs. Of 106 low-birth-weight infants at high risk for this inflammatory lung disease, 53 were given four intravenous doses of A1PI between days 0 and 14, while the others received a placebo. No significant difference was seen between the groups with respect to CLD, measured as requiring oxygen therapy at day 28. The treated group showed improved outcomes in the reduction of pulmonary hemorrhage and days of oxygen therapy required., Background. An imbalance between increased neutrophil elastase and a decreased antiprotease shield has been suggested as a factor contributing to the development of chronic lung disease (CLD). We hypothesized that administration of [[Alpha].sub.1]-proteinase inhibitor (A1PI), also known as [[Alpha].sub.1]-antitrypsin, to premature neonates would prevent CLD. Design. A randomized, placebo-controlled, prospective study of A1PI supplementation was performed. Neonates [is less than] 24 hours of age with birth weights 600-1000 g on respiratory support, and 1001-1250 g with respiratory distress syndrome (RDS) were eligible. Intravenous A1PI (60 mg/kg) or placebo was infused on days 0, 4, 7, and 14. Primary outcome was CLD in survivors, defined as the need for supplemental oxygen on day 28. Results. A total of 106 patients were recruited. There were no significant differences between groups in birth weight or incidence of RDS. The incidence of CLD in survivors was lower in the treated group, but the difference did not reach statistical significance (relative risk [RR], 0.79; confidence interval [CI], 0.60-1.02). This beneficial trend persisted at 36 weeks corrected gestational age (RR, 0.48; CI, 0.23-1.00). The incidence of pulmonary hemorrhage was lower in the treated group (RR, 0.22; CI, 0.05-0.98). Other complications were not significantly different between groups. Conclusions. In this, the first trial of a protease inhibitor for the prevention of CLD in premature infants, the infusions were well-tolerated. A1PI therapy may impede the development of CLD and appears to reduce the incidence of pulmonary hemorrhage in some neonates born prematurely. Pediatrics 1998;101:89-94; [[Alpha].sub.1]-proteinase inhibitor, bronchopulmonary dysplasia, infant, randomized, controlled trials; serine proteinase inhibitors:, ABBREVIATIONS. CLD, chronic lung disease; RDS, respiratory distress syndrome; A1PI, [[Alpha].sub.1]-proteinase inhibitor. Chronic lung disease (CLD) or bronchopulmonary dysplasia is the end result of unresolved neonatal acute lung injury.[1] Affected [...]