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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07725575

Enrollment

Registered

2026-07-24

Start date

2024-11-01

Completion date

2025-06-01

Last updated

2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopulmonary Dysplasia (BPD)

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

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

Interventions

DRUGExperimental

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

Randomized Clinical Trial

Eligibility

Sex/Gender

ALL

Age

No minimum to 48 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Bronchopulmonary dysplasia	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.

Countries

Indonesia

Contacts

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

Fakultas Kedokteran Universitas Indonesia

STUDY_DIRECTOREvelyn Phangkawira, dr. Sp. A