THE EFFECT OF NEBULIZED AZITHROMYCIN AS THERAPY FOR BRONCHOPULMONARY DYSPLASIA

Phase 4

Recruiting

• Conditions: Bronchopulmonary Dysplasia; Premature; Ventilation, Mechanical
• Interventions: Drug: Azithromycin neubilization; Device: Lung ultrasound

• Registration Number: NCT06584474
• Lead Sponsor: Alexandria University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-09-03
• Study First Posted: 2024-09-04
• Study Start: 2024-10-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-05
• Primary Completion: 2025-10-02
• Study Completion: 2025-11-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I : Azithromycin group	Azithromycin neubilization	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).
Group I : Azithromycin group	Lung ultrasound	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).
Group II: conventional treatment group	Lung ultrasound	Patients will not receive the medication, instead will receive 3 ml of nebulized normal saline as placebo control.

Primary Outcome Measures

Name	Time	Method
Lung Ultrasound assessment	14 days postnatal age.	Lung ultrasound score The score is calculated by the following points at different lung zones using lung ultrasound 0: A lines; 1. 3 or more nonconfluent B lines; 2. confluent B lines; 3. C profile or consolidation
Development of BPD (bronchopulmonary dysplasia)	28 days of life and/or 36 weeks postmenstrual age	Developed BPD :Yes or No If patient fulfilled criteria of BPD ; patient is born at or less than 32 weeks gestational age and still need oxygen and or respiratory support at the 28 day or more postnatal age and/or 36 weeks postmenstrual age.

Trial Locations

Locations (1)

Alexandria University; 🇪🇬 Alexandria, Egypt