(HealthDay News) — For extremely premature infants, early inhaled budesonide is associated with reduced incidence of bronchopulmonary dysplasia but may be linked to increased mortality, according to a study published online October 14 in the New England Journal of Medicine.
Dirk Bassler, MD, from the University of Zurich in Switzerland, and colleagues randomized 863 extremely premature infants to early (within 24 hours after birth) inhaled budesonide or placebo. At a postmenstrual age of 36 weeks, they assessed the primary outcome of death or bronchopulmonary dysplasia.
The researchers found that 40% of infants assigned to budesonide and 46.3% assigned to placebo died or had bronchopulmonary dysplasia (gestational-age-stratified relative risk, 0.86; 95% confidence interval, 0.75–1; P=0.05). The incidence of bronchopulmonary dysplasia was 27.8 and 38% in the budesonide and placebo groups, respectively (relative risk, 0.74; 95% confidence interval, 0.6–0.91; P=0.004); death occurred in 16.9 and 13.6%, respectively (relative risk, 1.24; 95% confidence interval, 0.91–1.69; P=0.17). The budesonide group had a lower proportion of infants who required surgical closure of a patent ductus arteriosus or reintubation (P=0.004 and P=0.03, respectively).
“In summary, we found a beneficial effect of budesonide on the risk of bronchopulmonary dysplasia, as well as a possible increase in mortality associated with its use,” the authors write.
Several authors disclosed financial ties to Chiesi Farmaceutici, which partially funded the study.