Bronchopulmonary Dysplasia (BPD)Phase 4NCT07725575
Efficacy of Intrathecal Administration of Budesonide to Prevent Bronchopulmonary Dysplasia
A Phase 4 study testing Experimental in people with Bronchopulmonary Dysplasia (BPD), run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- Bronchopulmonary Dysplasia (BPD)
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Nov 2024to 1 Jun 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- chromosom abnormality
- critical congenital heart disease
- congenital pulmonal disease
- Need surgery within 1 month
- mother with chorioamnionitis
- received postnatal corticosteroid before
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
Read the 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
- Conditions
- Bronchopulmonary Dysplasia (BPD)
- Being tested
- Experimental
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalDrug
budesonide 25 mg/kg + beractant 100 mg/kg administered intratracheal
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | budesonide 25 mg/kgBW administered with beractant 100 mg/kgBW intratracheal Receives: Drug: Experimental |
| No intervention | No intervention | Control group, will received surfactant intratracheal Control group will receive 100 mg/kgBB intratracheal within 48 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: subject collection: 8 months, data processing 1 month, publication 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Nov 2024
- Primary completion24 Apr 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary Dysplasia (BPD)Studies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adhi Teguh Perma Iskandar, Sp, Universitas Indonesia
- Investigators
- Adhi Teguh Perma Iskandar, Dr. dr. Sp. A(K), Principal investigator, Fakultas Kedokteran Universitas IndonesiaEvelyn Phangkawira, dr. Sp. A, Study director, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725575
- Sponsor's protocol ID
- 24-01-0155
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07725575
- Acronym / sponsor ID
- 24-01-0155
- Conditions
- Bronchopulmonary Dysplasia (BPD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Experimentalbudesonide 25 mg/kgBW administered with beractant 100 mg/kgBW intratracheal |
| No intervention | No intervention | –Control group, will received surfactant intratracheal Control group will receive 100 mg/kgBB intratracheal within 48 hours |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- chromosom abnormality
- critical congenital heart disease
- congenital pulmonal disease
- Need surgery within 1 month
- mother with chorioamnionitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimentalbudesonide 25 mg/kg + beractant 100 mg/kg administered intratracheal | Drug | Experimental |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adhi Teguh Perma Iskandar, Dr. dr. Sp. A(K) principal investigator
Fakultas Kedokteran Universitas Indonesia
Evelyn Phangkawira, dr. Sp. A study director
Fakultas Kedokteran Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Experimental in people with Bronchopulmonary Dysplasia (BPD), run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchopulmonary dysplasia (time frame: subject collection: 8 months, data processing 1 month, publication 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.