Efficacy of Intrathecal Administration of Budesonide to Prevent Bronchopulmonary Dysplasia

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

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

Study Overview

• Status: Completed
• Conditions: Bronchopulmonary Dysplasia (BPD)
• Intervention / Treatment: Drug: Experimental

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 4

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; budesonide 25 mg/kgBW administered with beractant 100 mg/kgBW intratracheal	Drug: Experimental; budesonide 25 mg/kg + beractant 100 mg/kg administered intratracheal
No Intervention: No intervention; Control group, will received surfactant intratracheal Control group will receive 100 mg/kgBB intratracheal within 48 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Adhi Teguh Perma Iskandar, Dr. dr. Sp. A(K), Fakultas Kedokteran Universitas Indonesia; Study Director: Evelyn Phangkawira, dr. Sp. A, Fakultas Kedokteran Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Actual): April 24, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Ventilator-Induced Lung Injury; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bronchopulmonary Dysplasia
• Other Study ID Numbers: 24-01-0155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No