Efficacy of Intrathecal Administration of Budesonide to Prevent Bronchopulmonary Dysplasia

NCT07725575 | Completed Phase 4

• 1 other identifier: 24-01-0155
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Bronchopulmonary dysplasia

  The primary outcome was the incidence of BPD of any severity at 36 weeks' postmenstrual age in infants born at \<32 weeks' gestation or weighing \<1500 g.

  subject collection: 8 months, data processing 1 month, publication 1 month

Study Arms (2)

Experimental

EXPERIMENTAL

budesonide 25 mg/kgBW administered with beractant 100 mg/kgBW intratracheal

Drug: Experimental

No intervention

NO INTERVENTION

Control group, will received surfactant intratracheal Control group will receive 100 mg/kgBB intratracheal within 48 hours

Interventions

Experimental DRUG

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

Experimental

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• newborn
• birth weight less than 1500 g
• gestational age less than 32 weeks
• less than 48 hours of age
• diagnosed as respiratory distress syndrome and need surfactant
• get parental consent

You may not qualify if:

• \- chromosom abnormality
• critical congenital heart disease
• congenital pulmonal disease
• Need surgery within 1 month
• mother with chorioamnionitis
• received postnatal corticosteroid before

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Adhi Teguh Perma Iskandar, Dr. dr. Sp. A(K)

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

• Evelyn Phangkawira, dr. Sp. A

  Fakultas Kedokteran Universitas Indonesia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This was a single-blind study. The intervention team was aware of the treatment allocation owing to preparation requirements, whereas the attending pediatricians and clinical staff responsible for patient management and outcome assessment were blinded to the group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: November 1, 2024
• Primary Completion: April 24, 2025
• Study Completion: June 1, 2025
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)