Bronchopulmonary DysplasiaPhase 4NCT06584474
THE EFFECT OF NEBULIZED AZITHROMYCIN AS THERAPY FOR BRONCHOPULMONARY DYSPLASIA
A Phase 4 study testing Azithromycin neubilization and Lung ultrasound in people with Bronchopulmonary Dysplasia and Premature, run by Alexandria University at 2 sites in Egypt.
Trial summary
The aim of the study is to determine the effectiveness of nebulized azithromycin therapy in prevention of BPD in very low birth weight preterm infants when compared with placebo. Read more about this study
- Who is it for?
- Ages 7 to 28 days
- Conditions the study is for
- Bronchopulmonary Dysplasia, Premature, Ventilation, Mechanical
- What is being tested?
- Azithromycin neubilization and Lung ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 2 Oct 2024to 2 Jul 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 7 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age less than 32 weeks and birth weight less than 1500 g.
- Infants who are still in need of respiratory support at day 7 of life (intubated, or by non-invasive mechanical ventilation, including CPAP and high-flow nasal cannula, or any form of oxygen therapy).
Who cannot join
- Gestational age ≥ 32 weeks.
- Newborns with congenital cyanotic heart diseases.
- Obvious major congenital malformations, known syndromes or chromosomal anomalies.
- Infants with signs compatible with the diagnosis of necrotizing enterocolitis (NEC) in the first week of life.
- Current use of steroids.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Alexandria University
Alexandria, 0325
Alexandria University
Alexandria, 0356
About this study
Official title: THE EFFECT OF NEBULIZED AZITHROMYCIN AS AN ADJUVANT PREVENTIVE THERAPY FOR BRONCHOPULMONARY DYSPLASIA IN PRETERM INFANTS
The aim of the study is to determine the effectiveness of nebulized azithromycin therapy in prevention of BPD in very low birth weight preterm infants when compared with placebo.
- Being tested
- Azithromycin neubilization, Lung ultrasound
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin neubilizationDrug
nebulized azithromycin (Xithrone, Amoun, Egypt) that will be initiated from day 7 of birth in a dose of 20 mg/kg/day in two divided doses for 3 weeks till the time of primary outcome assessment (at 28 days of age). Azithromycin solution for nebulization will be prepared from intravenous vials containing 500 mg lyophilized powder. First, each lyophilized powder vial will be prepared with 5 ml normal saline according to the manufacturer's instruction. The reconstituted solution will be diluted with 28.5 ml normal saline to make a final concentration of 17.5 mg/ml according to clinical pharmacy recommendation. For nebulization of azithromycin, 0.6 ml of final drug prepared solution will be taken for every
1 kg body weight of patient, then made up to 3 ml of normal saline and will be administered by Aerogen Jet Nebulizer every 12 hours using 8 liter/min of medical air or by face mask if not mechanically ventilated. According to the manufacturer's declaration, prepared azithro
Lung ultrasoundDevice
Device A mobile device (PHILIPS ® HD11 XE) with a 10-MHz linear probe will be used for chest ultrasound. It will be done at day 14 of postnatal life.
| Study group | Role | What they receive |
|---|---|---|
| Group I : Azithromycin group | Active comparator | Patients will receive nebulized azithromycin (Xithrone, Amoun, Egypt) that will be initiated from day 7 of birth in a dose of 20 mg/kg/day in two divided doses for 3 weeks till the time of primary outcome assessment (at 28 days of age). Receives: Drug: Azithromycin neubilization; Device: Lung ultrasound |
| Group II: conventional treatment group | Placebo comparator | Patients will not receive the medication, instead will receive 3 ml of nebulized normal saline as placebo control. Receives: Device: Lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of BPD (bronchopulmonary dysplasia)
Developed BPD :Yes or No If patient fulfilled criteria of BPD ; patient is born at or less than 32 weeks gestational age and still need oxygen and or respiratory support at the 28 day or more postnatal age and/or 36 weeks postmenstrual age.
Measured: 28 days of life and/or 36 weeks postmenstrual age
Lung Ultrasound assessment
Lung ultrasound score The score is calculated by the following points at different lung zones using lung ultrasound 0: A lines
- 3 or more nonconfluent B lines
- confluent B lines
- C profile or consolidation
Measured: 14 days postnatal age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start2 Oct 2024
- Primary completion2 Jun 2025
- Study completion2 Jul 2025
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 Alexandria UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohamed Farag, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584474
- Sponsor's protocol ID
- 0201867
- Status last verified
- Jul 2025
- First submitted
- 2 Sep 2024
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF NEBULIZED AZITHROMYCIN AS AN ADJUVANT PREVENTIVE THERAPY FOR BRONCHOPULMONARY DYSPLASIA IN PRETERM INFANTS
- ClinicalTrials.gov ID
- NCT06584474
- Acronym / sponsor ID
- 0201867
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 4 Sep 2024 (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 aim of the study is to determine the effectiveness of nebulized azithromycin therapy in prevention of BPD in very low birth weight preterm infants when compared with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I : Azithromycin group | Active comparator | Drug: Azithromycin neubilization, Device: Lung ultrasoundPatients will receive nebulized azithromycin (Xithrone, Amoun, Egypt) that will be initiated from day 7 of birth in a dose of 20 mg/kg/day in two divided doses for 3 weeks till the time of primary outcome assessment (at 28 days of age). |
| Group II: conventional treatment group | Placebo comparator | Device: Lung ultrasoundPatients will not receive the medication, instead will receive 3 ml of nebulized normal saline as placebo control. |
Who may qualify
- Ages
- 7 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Gestational age less than 32 weeks and birth weight less than 1500 g.
- Infants who are still in need of respiratory support at day 7 of life (intubated, or by non-invasive mechanical ventilation, including CPAP and high-flow nasal cannula, or any form of oxygen therapy).
Key exclusion criteria (5 listed)
- Gestational age ≥ 32 weeks.
- Newborns with congenital cyanotic heart diseases.
- Obvious major congenital malformations, known syndromes or chromosomal anomalies.
- Infants with signs compatible with the diagnosis of necrotizing enterocolitis (NEC) in the first week of life.
- Current use of steroids.
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 neubilizationnebulized azithromycin (Xithrone, Amoun, Egypt) that will be initiated from day 7 of birth in a dose of 20 mg/kg/day in two divided doses for 3 weeks till the time of primary outcome assessment (at 28 days of age). Azithromycin solution for nebulization will be prepared from intravenous vials containing 500 mg lyophilized powder. First, each lyophilized powder vial will be prepared with 5 ml normal saline according to the manufacturer's instruction. The reconstituted solution will be diluted with 28.5 ml normal saline to make a final concentration of 17.5 mg/ml according to clinical pharmacy recommendation. For nebulization of azithromycin, 0.6 ml of final drug prepared solution will be taken for every 1 kg body weight of patient, then made up to 3 ml of normal saline and will be administered by Aerogen Jet Nebulizer every 12 hours using 8 liter/min of medical air or by face mask if not mechanically ventilated. According to the manufacturer's declaration, prepared azithro | Drug | Group I : Azithromycin group |
| Lung ultrasoundDevice A mobile device (PHILIPS ® HD11 XE) with a 10-MHz linear probe will be used for chest ultrasound. It will be done at day 14 of postnatal life. | Device | Group I : Azithromycin group, Group II: conventional treatment group |
Primary outcome
Development of BPD (bronchopulmonary dysplasia)
Time frame: 28 days of life and/or 36 weeks postmenstrual age
Developed BPD :Yes or No If patient fulfilled criteria of BPD ; patient is born at or less than 32 weeks gestational age and still need oxygen and or respiratory support at the 28 day or more postnatal age and/or 36 weeks postmenstrual age.
Lung Ultrasound assessment
Time frame: 14 days postnatal age.
Lung ultrasound score The score is calculated by the following points at different lung zones using lung ultrasound 0: A lines 1. 3 or more nonconfluent B lines 2. confluent B lines 3. C profile or consolidation
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 20 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 neubilization and Lung ultrasound in people with Bronchopulmonary Dysplasia and Premature, run by Alexandria University at 2 sites in Egypt.
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 2 inclusion and 5 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 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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. Some participants in this study may receive a placebo. 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?
Development of BPD (bronchopulmonary dysplasia) (time frame: 28 days of life and/or 36 weeks postmenstrual age). The study lists 2 primary outcomes in all. 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 20 Jul 2025.