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Dose-escalation trial of budesonide in surfactant for prevention of bronchopulmonary dysplasia in extremely low gestational age high-risk newborns (SASSIE)

Pediatric Research Feb 05, 2020

McEvoy CT, Ballard PL, Ward RM, et al. - Since initial trials of lung-targeted budesonide (0.25 mg/kg) in surfactant to prevent bronchopulmonary dysplasia in premature infants showed benefit, researchers conducted this investigation to determine the optimal safe dose. Dose-escalation study of budesonide (0.025, 0.05, 0.10 mg/kg) in calfactatant in extremely low gestational age neonates (ELGANs) needing intubation at 3−14 days. Participants in the study were 24 infants with mean gestational age 25.0 weeks and 743 g birth weight requiring mechanical ventilation at mean age 6 days. Findings suggested that budesonide/surfactant did not have any clinical respiratory benefit for intubated ELGANs at any dosing level. One-tenth of the dose used in previous trials had the least systemic metabolic consequences and seemed effective for lung-targeted anti-inflammatory action.
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