HealthDay News — Use of inhaled glucocorticoids in extremely preterm infants for the prevention of bronchopulmonary dysplasia does not lead to a higher rate of neurodevelopmental disability at 2 years, according to a study published in the issue of the New England Journal of Medicine.
Dirk Bassler, MD, from University of Zurich, and colleagues randomly assigned 863 infants (gestational age, 23 weeks 0 days to 27 weeks 6 days) to receive early (within 24 hours after birth) inhaled budesonide or placebo. A long-term composite outcome of neurodevelopmental disability among survivors included cerebral palsy, cognitive delay (a Mental Development Index score of <85 on the Bayley Scales of Infant Development, Second Edition), deafness, or blindness at a corrected age of 18 to 22 months.
Based on follow-up data from 629 infants, the researchers found that 148 of 308 infants assigned to budesonide had neurodevelopmental disability vs 165 of 321 infants assigned to placebo (relative risk, adjusted for gestational age, 0.93; 95% CI, 0.80-1.09; P =.40). For individual components of the composite outcome there was similarly no significant differences. However, there were more deaths among infants randomized to budesonide, compared to those given placebo (RR, 1.37; 95% CI, 1.01-1.86; P =.04).
“We found no effect of budesonide on the risk of neurodevelopmental disability among surviving extremely preterm infants at 18 to 22 months of age,” the authors write. “However, the mortality rate was higher in the budesonide group.”
The research was funded by Chiesi Farmaceutici, which provided the study drugs free of charge.
Bassler D, Shinwell ES, Hallman M, et al. Long-term effects of inhaled budesonide for bronchopulmonary dysplasia. N Engl J Med. 2018;378(2):148-157.