Azithromycin in the Prevention of Lung Injury in Premature Newborn
Condition: Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Azithromycin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): the newborn group will receive intravenous azithromycin 10 mg / kg / day once daily for 5 days; the group of newborns will receive 0.9% saline once daily for 5 days
Other intervention name(s): group A; group B
Intervention MeSH terms: Azithromycin
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