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COMPLETED
NCT07725575
PHASE4

Efficacy of Intrathecal Administration of Budesonide to Prevent Bronchopulmonary Dysplasia

Sponsor: Indonesia University

View on ClinicalTrials.gov

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

Interventions

DRUG

Experimental

budesonide 25 mg/kg + beractant 100 mg/kg administered intratracheal

Locations (1)

Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, Indonesia