Azithromycin in the Prevention of Lung Injury in Premature Newborn

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Brief Title

Azithromycin in the Prevention of Lung Injury in Premature Newborn

Official Title

Randomized Clinical Trial: Use of Azithromycin to Prevent Lung Damage in Preterm Newborns Under Mechanical Ventilation

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
    

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 Phase

Phase 4

Study Type

Interventional


Primary Outcome

bronchopulmonary dysplasia

Secondary Outcome

 TNF

Condition

Bronchopulmonary Dysplasia

Intervention

Azithromycin

Study Arms / Comparison Groups

 azithromycin group
Description:  A control group composed of 40 newborns receiving azithromycin

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

80

Start Date

August 28, 2012

Completion Date

April 13, 2016

Primary Completion Date

April 13, 2016

Eligibility 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.
      

Gender

All

Ages

N/A - 72 Hours

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Rita de Cassia Silveira, , 



Administrative Informations


NCT ID

NCT03485703

Organization ID

110639


Responsible Party

Sponsor

Study Sponsor

Hospital de Clinicas de Porto Alegre


Study Sponsor

Rita de Cassia Silveira, Principal Investigator, Federal University of Rio Grande do Sul


Verification Date

March 2018