Azithromycin in the Prevention of Lung Injury in Premature Newborn

NCT ID: NCT03485703

Last Updated: 2018-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-28
• Study Completion Date: 2016-04-13

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.

Conditions

Bronchopulmonary Dysplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

azithromycin group

A control group composed of 40 newborns receiving azithromycin

Group Type: EXPERIMENTAL

Azithromycin

Intervention Type: DRUG

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

placebo group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Azithromycin

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

group A; group B

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.

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 72 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rita de Cassia Silveira

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

References

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.

Reference Type: DERIVED

PMID: 32894857 (View on PubMed)

Other Identifiers

110639

Identifier Type: -

Identifier Source: org_study_id