THE EFFECT OF NEBULIZED AZITHROMYCIN AS THERAPY FOR BRONCHOPULMONARY DYSPLASIA

Alexandria University

Status and phase: Completed; Phase 4

Conditions: Ventilation, Mechanical; Premature; Bronchopulmonary Dysplasia

Treatments: Device: Lung ultrasound; Drug: Azithromycin neubilization

Study type: Interventional

Funder types: Other

Identifiers

NCT06584474

0201867

Details and patient eligibility

About

The aim of the study is to determine the effectiveness of nebulized azithromycin therapy in prevention of BPD in very low birth weight preterm infants when compared with placebo.

Enrollment: 100 patients

Sex: All

Ages: 7 to 28 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Gestational age less than 32 weeks and birth weight less than 1500 g.
2. Infants who are still in need of respiratory support at day 7 of life (intubated, or by non-invasive mechanical ventilation, including CPAP and high-flow nasal cannula, or any form of oxygen therapy).

Exclusion criteria

• Gestational age ≥ 32 weeks.
• Newborns with congenital cyanotic heart diseases.
• Obvious major congenital malformations, known syndromes or chromosomal anomalies.
• Infants with signs compatible with the diagnosis of necrotizing enterocolitis (NEC) in the first week of life.
• Current use of steroids.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

Group I : Azithromycin group

Active Comparator group

Description:

Patients will receive nebulized azithromycin (Xithrone, Amoun, Egypt) that will be initiated from day 7 of birth in a dose of 20 mg/kg/day in two divided doses for 3 weeks till the time of primary outcome assessment (at 28 days of age).

Treatment:

Drug: Azithromycin neubilization

Device: Lung ultrasound

Group II: conventional treatment group

Placebo Comparator group

Description:

Patients will not receive the medication, instead will receive 3 ml of nebulized normal saline as placebo control.

Treatment:

Device: Lung ultrasound