Budesonide plus surfactant does little to reduce BPD, death in preemies

In the treatment of extremely preterm infants, the combination of budesonide plus surfactant does not appear to reduce the risk of bronchopulmonary dysplasia (BPD) or death, as reported in a study.

The study included 641 infants within 22–28 weeks of gestation (mean 25.9 weeks) or had a birth weight of 401–1,000 g (mean 810 g). These infants were randomly assigned to receive surfactant alone (poractant alfa) or in combination with one to two doses of budesonide 0.25 mg/kg. Treatment was administered via endotracheal tube within 50 hours of birth.

Physiologic BPD or death by 36 weeks of postmenstrual age was the primary outcome. Safety was evaluated, along with other secondary and prespecified exploratory outcomes.

The study was terminated early at 55.3 percent of 1,160 planned enrolment due to futility. The incidence of BPD or death was similar in the two treatment arms: 68.5 percent with budesonide plus surfactant group vs 67.9 percent with surfactant alone (adjusted relative risk [RR], 1.00, 95 percent confidence interval [CI], 0.90–1.11).

No significant differences were observed in either mortality (15.3 percent vs 13.2 percent; adjusted RR, 1.13, 95 percent CI, 0.78–1.64) or BPD (62.9 percent vs 63 percent; adjusted RR, 0.99, 95 percent CI, 0.87–1.12).

Hyperglycaemia occurred more frequently among infants who received budesonide plus surfactant than those who received surfactant alone (66.7 percent vs 49.8 percent; adjusted RR, 1.33, 95 percent CI, 1.17–1.51).