"A multicenter clinical trial has found that intratracheal steroids do not reduce the risk of lung disease or death in extremely preterm infants, according to a study recently published in JAMA. The results challenge earlier findings from smaller studies in which investigators added the anti-inflammatory drug budesonide to the current standard surfactant therapy in hopes of reducing the risk of chronic lung disease or death in extremely preterm infants, said Marta Perez, MD, assistant professor of Pediatrics in the Division of Neonatology, who was a co-author of the study."
"Despite hopes that the combination therapy might improve outcomes, the trial was halted early after an interim analysis showed no significant benefit. The incidence of bronchopulmonary dysplasia or death by 36 weeks of age was nearly identical between the two groups: 68.5 percent in the budesonide-surfactant group versus 67.9 percent in the surfactant-only group."
Intratracheal budesonide added to surfactant therapy did not reduce bronchopulmonary dysplasia (BPD) or death among extremely preterm infants. A randomized multicenter trial enrolled 641 infants born at 22 to 28 weeks' gestation or weighing 401 to 1000 grams; all received surfactant within 50 hours of birth, and half received an added dose of budesonide. An interim analysis led to early trial cessation for lack of benefit. The combined outcome of BPD or death by 36 weeks occurred in 68.5% of the budesonide-surfactant group and 67.9% of the surfactant-only group. Earlier smaller trials suggesting benefit lacked equivalent scale and rigor.
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