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Efficacy of Intrathecal Administration of Budesonide to Prevent Bronchopulmonary Dysplasia

NCT07725575 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-07-24

No results posted yet for this study

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

Conditions

  • Bronchopulmonary Dysplasia (BPD)

Interventions

DRUG

Experimental

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

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Adhi Teguh Perma Iskandar, Dr. dr. Sp. A(K) · Fakultas Kedokteran Universitas Indonesia

  • Evelyn Phangkawira, dr. Sp. A · Fakultas Kedokteran Universitas Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-04-24
Completion
2025-06-01

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07725575 on ClinicalTrials.gov