THE EFFECT OF NEBULIZED AZITHROMYCIN AS THERAPY FOR BRONCHOPULMONARY DYSPLASIA

NCT06584474 | Completed Phase 4 DMC

• 1 other identifier: 0201867
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Bronchopulmonary Dysplasia; Premature; Ventilation, Mechanical

Outcome Measures

Primary Outcomes (2)

• Development of BPD (bronchopulmonary dysplasia)

  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.

  28 days of life and/or 36 weeks postmenstrual age

• Lung Ultrasound assessment

  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

  14 days postnatal age.

Study Arms (2)

Group I : Azithromycin group

ACTIVE COMPARATOR

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).

Drug: Azithromycin neubilization; Device: Lung ultrasound

Group II: conventional treatment group

PLACEBO COMPARATOR

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

Device: Lung ultrasound

Interventions

Azithromycin neubilization DRUG

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). Azithromycin solution for nebulization will be prepared from intravenous vials containing 500 mg lyophilized powder. First, each lyophilized powder vial will be prepared with 5 ml normal saline according to the manufacturer's instruction. The reconstituted solution will be diluted with 28.5 ml normal saline to make a final concentration of 17.5 mg/ml according to clinical pharmacy recommendation. For nebulization of azithromycin, 0.6 ml of final drug prepared solution will be taken for every 1 kg body weight of patient, then made up to 3 ml of normal saline and will be administered by Aerogen Jet Nebulizer every 12 hours using 8 liter/min of medical air or by face mask if not mechanically ventilated. According to the manufacturer's declaration, prepared azithro

Group I : Azithromycin group

Lung ultrasound DEVICE

Device A mobile device (PHILIPS ® HD11 XE) with a 10-MHz linear probe will be used for chest ultrasound. It will be done at day 14 of postnatal life.

Group I : Azithromycin group; Group II: conventional treatment group

Eligibility Criteria

• Age: 7 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age less than 32 weeks and birth weight less than 1500 g.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (2)

Alexandria University

Alexandria, 0325, Egypt

Location

Alexandria University

Alexandria, 0356, Egypt

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth; Respiratory Aspiration

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; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of pediatrics at Alexandria University

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 4, 2024
• Study Start: October 2, 2024
• Primary Completion: June 2, 2025
• Study Completion: July 2, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

EG (2)