Early intratracheal budesonide does little to improve outcomes in preemies

Early intratracheal budesonide in extremely preterm infants receiving surfactant for respiratory distress syndrome appears to be of little to no benefit in terms of survival free of bronchopulmonary dysplasia (BPD), according to a study.

The study included 1,059 infants who were born at <28 weeks of gestation and less than 48 hours old, were mechanically ventilated or receiving noninvasive respiratory support, and were clinically indicated for surfactant therapy. These infants were randomly assigned to receive budesonide 0.25 mg/kg mixed with surfactant (n=524) or surfactant only (n=535). Treatment was administered via an endotracheal tube or thin catheter.

Survival free of BPD at 36 weeks’ postmenstrual age was the primary outcome. Secondary outcomes included the two components of the primary outcome—survival at 36 weeks and BPD incidence—among others, and as well as safety.

Overall, the mean gestational age of the infants was 25.6 weeks, while the mean birth weight was 775 g. More than half of the infants (55.3 percent) were male. Of the infants, 134 (25.6 percent) in the budesonide and surfactant group and 121 (22.6 percent) in the surfactant-only group survived free of BPD (adjusted risk difference, 2.7 percent, 95 percent confidence interval, −2.1 to 7.4).

At 36 weeks’ postmenstrual age, the percentage of infants who were alive was 83.2 percent in the budesonide and surfactant group and 80.6 percent in the surfactant-only group. Of these, 69.3 percent and 71.9 percent, respectively, received a BPD diagnosis.