Azithromycin in the Prevention of Lung Injury in Premature Newborn

NCT03485703 | Completed Phase 4

• 1 other identifier: 110639
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Conditions

Bronchopulmonary Dysplasia

Outcome Measures

Primary Outcomes (1)

• bronchopulmonary dysplasia

  neonate that needs to use oxygen in concentrations above 21% for a period greater than or equal to 28 days

  28 days

Secondary Outcomes (6)

• TNF

  5 days

• IL-10

  5 days

• IL-6

  5 days

• IL-8

  5 days

• IL1b

  5 days

Study Arms (2)

azithromycin group

EXPERIMENTAL

A control group composed of 40 newborns receiving azithromycin

Drug: Azithromycin

placebo group

PLACEBO COMPARATOR

comparative group composed of 40 newborns who would receive saline 0.9%

Drug: Placebo

Interventions

Azithromycin DRUG

the newborn group will receive intravenous azithromycin 10 mg / kg / day once daily for 5 days

Also known as: group A

azithromycin group

Placebo DRUG

the group of newborns will receive 0.9% saline once daily for 5 days

Also known as: group B

placebo group

Eligibility Criteria

• Age: 1 Minute - 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Related Publications (1)

• 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.

  PMID: 32894857 DERIVED

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Rita de Cassia Silveira

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2018
• First Posted: April 2, 2018
• Study Start: August 28, 2012
• Primary Completion: April 13, 2016
• Study Completion: April 13, 2016
• Last Updated: April 2, 2018

Record last verified: 2018-03