Bronchopulmonary DysplasiaPhase 4NCT03485703
Azithromycin in the Prevention of Lung Injury in Premature Newborn
A Phase 4 study testing Azithromycin in people with Bronchopulmonary Dysplasia, run by Hospital de Clinicas de Porto Alegre.
Trial summary
The introduction of invasive mechanical ventilation in the treatment of preterm infants works as an adjuvant in the treatment of acute respiratory failure, which has resulted in significantly significant survival rates. Read more about this study
- Who is it for?
- Ages 1 minute to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Azithromycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 28 Aug 2012to 13 Apr 2016
- 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 1 minute to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- preterm infants of less than 37 weeks of gestational age who have undergone mechanical ventilation within the first 72 hours of life
Who cannot join
- Major congenital malformations or chromosomal syndromes Mothers carrying the HIV virus.
About this study
Official title: Randomized Clinical Trial: Use of Azithromycin to Prevent Lung Damage in Preterm Newborns Under Mechanical Ventilation
The introduction of invasive mechanical ventilation in the treatment of preterm infants works as an adjuvant in the treatment of acute respiratory failure, which has resulted in significantly significant survival rates. In recent years there has been an increase in the number of evidence that mechanical factors can cause lung injury through inflammatory cells and soluble mediators.
The alveolar and airway epithelium is an important source of cytokine release. Cytokines are very low molecular weight proteins or glycoproteins with hormone-like actions. They contribute to the pathogenesis of various diseases through the ability to induce other inflammatory mediators Mechanical ventilation strategies can increase pulmonary and systemic cytokines and lead to dysfunction of multiple organs and systems.
Azithromycin has a potent anti-inflammatory and immunomodulatory effect It suppresses the production of proinflammatory cytokines (IL-6, IL-1, and TNF-α), has effective antimicrobial properties against Ureaplasma and, best of all, few side effects The hypothesis of this study is that azithromycin would reduce pulmonary inflammation induced by mechanical ventilation in premature infants, conferring a protective character.Randomized clinical trial: use of azithromycin in preventing pulmonary damage newborn preterm undergoing mechanical ventilation
Read the detailed description
The nature of lung injury induced by mechanical ventilation is clearly established, including the release of immunoinflammatory mediators. However, safe drug therapy that decreases its severity is not available. Azithromycin is a macrolide antibiotic with potent anti-inflammatory effects, but has been poorly studied in preterm infants except for very few studies in extreme preterms for the prevention of bronchopulmonary dysplasia.
The aim of this study was to evaluate the effect of azithromycin on the prevention of cytokine-mediated MV-induced injury in cytokine plasma levels (IL-1β, IL-2, IL-6, IL-8, IL-10 and TNF- α) in preterm newborns, submitted to mechanical ventilation in the first 72 hours of life.
It is a double-blind placebo controlled clinical trial. When the use of azithromycin was considered, after signing the informed consent, a randomization was performed by the intravenous mixtures center of Hospital de clinicas de porto alegre where a group of newborns will receive azithromycin EV at the dose of 10mg / kg / day and another group will receive placebo (SF 0.9%) in the same volume, a blood aliquot of 300μL will be collected in all ETDA for cytokine analysis and PCR for Ureaplasma. After 5 days of starting azithromycin or placebo, a new sample will be collected for cytokines along with blood collection from the patient's routine. There will be no blood collection exclusively for the study.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- Azithromycin, Placebo
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Also called group A
the newborn group will receive intravenous azithromycin 10 mg / kg / day once daily for 5 days
PlaceboDrug
Also called group B
the group of newborns will receive 0.9% saline once daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| azithromycin group | Experimental | A control group composed of 40 newborns receiving azithromycin Receives: Drug: Azithromycin |
| placebo group | Placebo comparator | comparative group composed of 40 newborns who would receive saline 0.9% Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
bronchopulmonary dysplasia
neonate that needs to use oxygen in concentrations above 21% for a period greater than or equal to 28 days
Measured: 28 days
Secondary outcomes (6)
TNF
decreasing in plasma levels after treatment with azitromicina
Measured: 5 days
IL-10
increasing in plasma levels after treatment with azitromicina
Measured: 5 days
IL-6
increasing in plasma levels after treatment with azitromicina
Measured: 5 days
IL-8
increasing in plasma levels after treatment with azitromicina
Measured: 5 days
IL1b
increasing in plasma levels after treatment with azitromicina
Measured: 5 days
IL2
increasing in plasma levels after treatment with azitromicina
Measured: 5days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start28 Aug 2012
- Primary completion13 Apr 2016
- Study completion13 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- for a period of 5 days, a group of infants will receive azithromycin EV at a dose of 10 mg / kg / day and another group will receive placebo (SF 0.9%) in the same volume, every 24 hours.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rita de Cassia Silveira, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485703
- Sponsor's protocol ID
- 110639
- Status last verified
- Mar 2018
- First submitted
- 25 Mar 2018
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nunes CR, Procianoy RS, Corso AL, Silveira RC. Use of Azithromycin for the Prevention of Lung Injury in Mechanically Ventilated Preterm Neonates: A Randomized Controlled Trial. Neonatology. 2020;117(4):522-528. doi: 10.1159/000509462. Epub 2020 Sep 7.
PubMed 32894857
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial: Use of Azithromycin to Prevent Lung Damage in Preterm Newborns Under Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT03485703
- Acronym / sponsor ID
- 110639
- Conditions
- Bronchopulmonary Dysplasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 28 Aug 2012 (actual)
- Primary completion
- 13 Apr 2016 (actual)
- Study completion
- 13 Apr 2016 (actual)
- First posted
- 2 Apr 2018 (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 introduction of invasive mechanical ventilation in the treatment of preterm infants works as an adjuvant in the treatment of acute respiratory failure, which has resulted in significantly significant survival rates. In recent years there has been an increase in the number of evidence that mechanical factors can cause lung injury through inflammatory cells and soluble mediators.
The alveolar and airway epithelium is an important source of cytokine release. Cytokines are very low molecular weight proteins or glycoproteins with hormone-like actions. They contribute to the pathogenesis of various diseases through the ability to induce other inflammatory mediators Mechanical ventilation strategies can increase pulmonary and systemic cytokines and lead to dysfunction of multiple organs and systems.
Azithromycin has a potent anti-inflammatory and immunomodulatory effect It suppresses the production of proinflammatory cytokines (IL-6, IL-1, and TNF-α), has effective antimicrobial properties against Ureaplasma and, best of all, few side effects The hypothesis of this study is that azithromycin would reduce pulmonary inflammation induced by mechanical ventilation in premature infants, conferring a protective character.Randomized clinical trial: use of azithromycin in preventing pulmonary damage newborn preterm undergoing mechanical ventilation
Detailed description
The nature of lung injury induced by mechanical ventilation is clearly established, including the release of immunoinflammatory mediators. However, safe drug therapy that decreases its severity is not available. Azithromycin is a macrolide antibiotic with potent anti-inflammatory effects, but has been poorly studied in preterm infants except for very few studies in extreme preterms for the prevention of bronchopulmonary dysplasia.
The aim of this study was to evaluate the effect of azithromycin on the prevention of cytokine-mediated MV-induced injury in cytokine plasma levels (IL-1β, IL-2, IL-6, IL-8, IL-10 and TNF- α) in preterm newborns, submitted to mechanical ventilation in the first 72 hours of life.
It is a double-blind placebo controlled clinical trial. When the use of azithromycin was considered, after signing the informed consent, a randomization was performed by the intravenous mixtures center of Hospital de clinicas de porto alegre where a group of newborns will receive azithromycin EV at the dose of 10mg / kg / day and another group will receive placebo (SF 0.9%) in the same volume, a blood aliquot of 300μL will be collected in all ETDA for cytokine analysis and PCR for Ureaplasma. After 5 days of starting azithromycin or placebo, a new sample will be collected for cytokines along with blood collection from the patient's routine. There will be no blood collection exclusively for the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- for a period of 5 days, a group of infants will receive azithromycin EV at a dose of 10 mg / kg / day and another group will receive placebo (SF 0.9%) in the same volume, every 24 hours.
| Arm | Type | Receives |
|---|---|---|
| azithromycin group | Experimental | Drug: AzithromycinA control group composed of 40 newborns receiving azithromycin |
| placebo group | Placebo comparator | Drug: Placebocomparative group composed of 40 newborns who would receive saline 0.9% |
Who may qualify
- Ages
- 1 minute to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- preterm infants of less than 37 weeks of gestational age who have undergone mechanical ventilation within the first 72 hours of life
Key exclusion criteria (1 listed)
- Major congenital malformations or chromosomal syndromes Mothers carrying the HIV virus.
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 |
|---|---|---|
| AzithromycinAlso: group Athe newborn group will receive intravenous azithromycin 10 mg / kg / day once daily for 5 days | Drug | azithromycin group |
| PlaceboAlso: group Bthe group of newborns will receive 0.9% saline once daily for 5 days | Drug | placebo group |
Primary outcome
bronchopulmonary dysplasia
Time frame: 28 days
neonate that needs to use oxygen in concentrations above 21% for a period greater than or equal to 28 days
6 secondary outcomes
TNF
Time frame: 5 days
IL-10
Time frame: 5 days
IL-6
Time frame: 5 days
IL-8
Time frame: 5 days
IL1b
Time frame: 5 days
IL2
Time frame: 5days
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 2 Apr 2018.
- Derived from this study: PubMed 32894857Nunes CR, Procianoy RS, Corso AL, Silveira RC. Use of Azithromycin for the Prevention of Lung Injury in Mechanically Ventilated Preterm Neonates: A Randomized Controlled Trial. Neonatology. 2020;117(4):522-528. doi: 10.1159/000509462. Epub 2020 Sep 7.
- Individual participant dataSharing planned: Undecided
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.
Rita de Cassia Silveira principal investigator
Federal University of Rio Grande do Sul
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azithromycin in people with Bronchopulmonary Dysplasia, run by Hospital de Clinicas de Porto Alegre.
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 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
bronchopulmonary dysplasia (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03485703, which also lists 1 linked publication.
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 2 Apr 2018.