PEDIATRICS Vol. 101 No. 1 January 1998, pp. 89-94
1-Proteinase Inhibitor Therapy
for the Prevention of Chronic Lung Disease of Prematurity: A
Randomized, Controlled Trial
Received May 19, 1997; accepted Sep 16, 1997.
,
,,,
From * Women's College Hospital, Mount Sinai Hospital, the
§ Hospital for Sick Children and the University of Toronto, Toronto,
Ontario, Canada.
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
1-proteinase inhibitor (A1PI), also known as
1-antitrypsin, to premature neonates would prevent CLD.
Design. A randomized, placebo-controlled, prospective study of A1PI supplementation was performed. Neonates <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.
Key words:1-proteinase
inhibitor,
bronchopulmonary dysplasia,
infant,
randomized,
controlled
trials,
serine proteinase inhibitors.
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