Bronchopulmonary DysplasiaPhase 4NCT05311228
The Efect of Azithromicyn on Bronchopulmonary Displasia in Extremely Preterm and Very Preterm Infant
A Phase 4 study testing Azithromycin Powder in people with Bronchopulmonary Dysplasia and Intraventricular Hemorrhage, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study was to see the effectiveness of azithromycin in preventing the incidence of bronchopulmonary dysphasia in extremely preterm and very premature infants. Inclusion criteria were infants with a gestational age of 25-31 weeks 6 days who experienced respiratory distress and their families had agreed to… Read more about this study
- Who is it for?
- Ages 25 to 32 weeks
- Conditions the study is for
- Bronchopulmonary Dysplasia, Intraventricular Hemorrhage, Necrotizing Enterocolitis
- What is being tested?
- Azithromycin Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndonesia
- Study dates
- 8 Jun 2021to 1 Apr 2022
- 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 25 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- premature infant 25-31 weeks 6 days with respiratory distress,
Who cannot join
- multiple congenital anomaly
Trial locations and contacts
1 site in 1 country.
About this study
This study was to see the effectiveness of azithromycin in preventing the incidence of bronchopulmonary dysphasia in extremely preterm and very premature infants. Inclusion criteria were infants with a gestational age of 25-31 weeks 6 days who experienced respiratory distress and their families had agreed to participate in the study, then randomized. The intervention was in the form of giving azithromycin in the intervention group and no intervention was carried out in the control group and then followed up to 36 weeks PMA
- Being tested
- Azithromycin Powder
- Medical subject headings
- Bronchopulmonary Dysplasia, Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin PowderDrug
Azithromicyn intravena for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention group will give azithromycin for 14 days, 7 days 10 mg/body weight/24 hours, 7 days 5 mg/bw/hours Receives: Drug: Azithromycin Powder |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchopulmonaty Dysplasia
Use of oxygen suplemantation at least 28 days until 36 weeks PMA
Measured: BPD mild room air until 36 weeks PMA, BPD moderate use of oxygen <30% until 36 weeks PMA, BPD severe use of oxygen >30% until 36 weeks PMA
Secondary outcomes (2)
Intraventricular hemorrhage
Sign of IVH from head ultrasonography from USG we can found the sign of IVH grade 1 if we perform head USG and we found bleeding in germinal matriks grade 2 if we perform head USG and we found bleeding intaventricular without ventricle dilatation grade 3 if we perform head USG we found bleeding intraventrucular with dilatation of ventricle grade 4 if we perform head USG and we found bleeding in parenchime
Head USG perform at 1-7 days and then in 6 weeks
Measured: 1 days-7 days, and 6 weeks
Necrotizing Enterocolitis
Sign and symptoms of NEC from clinical, laboratory, and radiology
If we found :
From clinical sign : temperature < 36.5 degree C or > 37.5 degree C, Respiratory rate > 60/min with retraction, abdominal distention Laboratory examination : trombocyte < 100.000/mm3, natrium <135 meq/L, pH < 7.1, BE > -12, CRP > 5 IU Radiology examination : sign of pneumatosis intestinalis
NEC : clinically + laboratory + radiology
Measured: 1 days-36 weeks PMA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start8 Jun 2021
- Primary completion1 Mar 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies 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
- Two groups, one group intervention and one group control
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Besse Sarmila, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311228
- Sponsor's protocol ID
- 21050544
- Status last verified
- Mar 2024
- First submitted
- 22 Jan 2022
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Maybe i will share IPD with other researcher
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efect of Azithromicyn on Bronchopulmonary Displasia in Extremely Preterm and Very Preterm Infant
- ClinicalTrials.gov ID
- NCT05311228
- Acronym / sponsor ID
- 21050544
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 5 Apr 2022 (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.
This study was to see the effectiveness of azithromycin in preventing the incidence of bronchopulmonary dysphasia in extremely preterm and very premature infants. Inclusion criteria were infants with a gestational age of 25-31 weeks 6 days who experienced respiratory distress and their families had agreed to participate in the study, then randomized. The intervention was in the form of giving azithromycin in the intervention group and no intervention was carried out in the control group and then followed up to 36 weeks PMA
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups, one group intervention and one group control
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Azithromycin PowderIntervention group will give azithromycin for 14 days, 7 days 10 mg/body weight/24 hours, 7 days 5 mg/bw/hours |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 25 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- premature infant 25-31 weeks 6 days with respiratory distress,
Key exclusion criteria (1 listed)
- multiple congenital anomaly
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 |
|---|---|---|
| Azithromycin PowderAzithromicyn intravena for 14 days | Drug | Intervention group |
Primary outcome
Bronchopulmonaty Dysplasia
Time frame: BPD mild room air until 36 weeks PMA, BPD moderate use of oxygen <30% until 36 weeks PMA, BPD severe use of oxygen >30% until 36 weeks PMA
Use of oxygen suplemantation at least 28 days until 36 weeks PMA
2 secondary outcomes
Intraventricular hemorrhage
Time frame: 1 days-7 days, and 6 weeks
Necrotizing Enterocolitis
Time frame: 1 days-36 weeks PMA
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 8 Mar 2024.
- Individual participant dataSharing planned: Undecided. Maybe i will share IPD with other researcher
Related trials for Bronchopulmonary Dysplasia
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Azithromycin Powder in people with Bronchopulmonary Dysplasia and Intraventricular Hemorrhage, 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 1 inclusion and 1 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 8 Mar 2024. 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?
Bronchopulmonaty Dysplasia (time frame: BPD mild room air until 36 weeks PMA, BPD moderate use of oxygen <30% until 36 weeks PMA, BPD severe use of oxygen >30% until 36 weeks PMA). 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 8 Mar 2024.