Efficacy of Intrathecal Administration of Budesonide to Prevent Bronchopulmonary Dysplasia

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bronchopulmonary Dysplasia (BPD) Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

Up to 48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

About this study

Subject is all neonates born with gestational age less than 32 weeks or birth weight under 1500 g with respiratory distress syndrome and need surfactant was randomized into two groups: intervention and control Intervention group will received budesonide (pulmicort) 0.25 mg/kgBB diluted with beractant (survanta) 100 mg/kgBB intratracheal, the solution is divided into 3 aliquotes Control group will received beractant (survanta) 100 mg/kgBB intratracheal divided into 3 aliquotes All subjects will be followed up until 36 weeks post menstruational age do define whether the developed bronchopulmonary dysplasia or not

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

chromosom abnormality

critical congenital heart disease
congenital pulmonal disease
Need surgery within 1 month
mother with chorioamnionitis
received postnatal corticosteroid before

Treatment and study plan

Experimental

Drug

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

Primary outcomes

Bronchopulmonary dysplasia

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

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.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jul 24, 2026
Registry last updated: Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed