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Azithromycin in the Prevention of Lung Injury in Premature Newborn

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03485703
Recruitment Status : Completed
First Posted : April 2, 2018
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief 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. 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


Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Drug: Azithromycin Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Randomized Clinical Trial: Use of Azithromycin to Prevent Lung Damage in Preterm Newborns Under Mechanical Ventilation
Actual Study Start Date : August 28, 2012
Actual Primary Completion Date : April 13, 2016
Actual Study Completion Date : April 13, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: azithromycin group
A control group composed of 40 newborns receiving azithromycin
Drug: Azithromycin
the newborn group will receive intravenous azithromycin 10 mg / kg / day once daily for 5 days
Other Name: group A

Placebo Comparator: placebo group
comparative group composed of 40 newborns who would receive saline 0.9%
Drug: Placebo
the group of newborns will receive 0.9% saline once daily for 5 days
Other Name: group B




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. TNF [ Time Frame: 5 days ]
    decreasing in plasma levels after treatment with azitromicina

  2. IL-10 [ Time Frame: 5 days ]
    increasing in plasma levels after treatment with azitromicina

  3. IL-6 [ Time Frame: 5 days ]
    increasing in plasma levels after treatment with azitromicina

  4. IL-8 [ Time Frame: 5 days ]
    increasing in plasma levels after treatment with azitromicina

  5. IL1b [ Time Frame: 5 days ]
    increasing in plasma levels after treatment with azitromicina

  6. IL2 [ Time Frame: 5days ]
    increasing in plasma levels after treatment with azitromicina



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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • preterm infants of less than 37 weeks of gestational age who have undergone mechanical ventilation within the first 72 hours of life

Exclusion Criteria:

  • Major congenital malformations or chromosomal syndromes Mothers carrying the HIV virus.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03485703


Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Rita de Cassia Silveira Federal University of Rio Grande do Sul

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03485703    
Other Study ID Numbers: 110639
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases