Clinical Trial

Efficacy of Intrathecal Administration of Budesonide to Prevent Bronchopulmonary Dysplasia

Completed Phase 4
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Summary
The goal of this clinical trial is to learn if budesonide works to prevent bronchopulmonary dysplasia in newborn less than 32 weeks gestational age or birth weight less than 1500 g with respiratory distress syndrome who needs surfactants. Does budesonide lower the incidence of bronchopulmonary dysplasia? What medical problems do participants have after given budesonide? Researchers will compare intratracheal budesonide and surfactant to intratracheal surfactant only to see if budesonide works to prevent bronchopumonary dysplasia. Participants will: Given intratracheal budesonide and surfactant and followed up until 36 weeks of post menstrual age to determine whether they have bronchopulmonary dysplasia or not
Trial Details
NCT Number NCT07725575
Lead Sponsor Indonesia University
Conditions Bronchopulmonary Dysplasia (BPD)
Enrollment 86 participants
Start Date 2024-11-01
Primary Completion 2025-04-24 (estimated)
Study Completion 2025-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-24