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Efficacy of Intrathecal Administration of Budesonide to Prevent Bronchopulmonary Dysplasia
Sponsor: Indonesia University
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
Official title: Efficacy Of Intratracheal Administration Of Budesonide To Prevent Bronchopulmonary Dysplasia In Neonate With Gestational Age Less Than 32 Weeks/Birth Weight Less Than 1500 Grams With Respiratory Distress Syndrome Who Received Surfactant
Key Details
Gender
All
Age Range
Any - 48 Hours
Study Type
INTERVENTIONAL
Enrollment
86
Start Date
2024-11-01
Completion Date
2025-06-01
Last Updated
2026-07-24
Healthy Volunteers
No
Conditions
Interventions
Experimental
budesonide 25 mg/kg + beractant 100 mg/kg administered intratracheal
Locations (1)
Cipto Mangunkusumo Hospital
Jakarta, DKI Jakarta, Indonesia