January 19, 2018
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Budesonide for preterm infants unrelated to neurodevelopmental disability

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Budesonide for the prevention and treatment of bronchopulmonary dysplasia in extremely preterm infants is not associated with an additional risk of neurodevelopmental disability when compared with placebo; however, infants who receive this medication experience a higher risk of mortality.

“Neonatal pharmacologic therapies are an important tool for reducing the burden of bronchopulmonary dysplasia,” Dick Bassler, MD, from the department of neonatology at University Hospital Zurich within the University of Zurich, Switzerland, and colleagues wrote. “Systemic glucocorticoids are effective for the prevention of bronchopulmonary dysplasia but can increase the risk of neurodevelopmental impairment … Despite their widespread use, inhaled glucocorticoids have been evaluated in only a few small, short-term studies.”

To determine the lasting effects of inhaled glucocorticoids for the treatment and prevention of bronchopulmonary dysplasia on neurodevelopment in extremely preterm infants, the researchers conducted a study in which infants with a gestational age of 23 to 27 weeks, 6 days received either inhaled budesonide or a placebo within 24 hours of birth. Bassler and colleagues then assessed neurodevelopmental disability — including cerebral palsy, cognitive delay with a Mental Development Index Score of less than 85 on the Bayley Scales of Infant Development, and deafness or blindness at the corrected age of 18 to 22 months —  among children who survived.

Of the 629 infants for which adequate data were available, 48.1% of the infants assigned to budesonide (n = 308) had a neurodevelopmental disability, whereas 51.4% of the infants who received a placebo (n = 321) had a neurodevelopmental disability (RR, adjusted for gestational age = 0.93; 95% CI, 0.80-1.09).

No significant difference was observed between each component within the outcome. Of the infants who were administered budesonide, 19.9% died, whereas 14.5% of infants in the placebo group died (RR = 1.37; 95% CI, 1.01-1.86; P = .04).

 “When we designed the trial, we did not anticipate an effect of inhaled budesonide on mortality, and thus our prespecified long-term composite outcome did not include mortality as a component,” Bassler and colleagues wrote. “However, at the time of assessment of the primary outcome, budesonide was associated with a nonsignificant excess in mortality. This unexpected finding prompted us to assess additional exploratory long-term outcomes, including mortality at the time of follow-up assessment and a composite outcome of death or severe neurodevelopmental disability.” – by Katherine Bortz

Disclosures: The authors report no relevant financial disclosures.