THE EFFECT OF NEBULIZED AZITHROMYCIN AS THERAPY FOR BRONCHOPULMONARY DYSPLASIA

THE EFFECT OF NEBULIZED AZITHROMYCIN AS AN ADJUVANT PREVENTIVE THERAPY FOR BRONCHOPULMONARY DYSPLASIA IN PRETERM INFANTS

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.

Study Overview

• Status: Completed
• Conditions: Bronchopulmonary Dysplasia; Premature; Ventilation, Mechanical
• Intervention / Treatment: Drug: Azithromycin neubilization; Device: Lung ultrasound

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 0325
    • Alexandria University
  • Alexandria, Egypt, 0356
    • Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I : Azithromycin group; 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; 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; Device: Lung ultrasound; 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.
Placebo Comparator: Group II: conventional treatment group; Patients will not receive the medication, instead will receive 3 ml of nebulized normal saline as placebo control.	Device: Lung ultrasound; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; 3 or more nonconfluent B lines; confluent B lines; C profile or consolidation	14 days postnatal age.

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2024
• Primary Completion (Actual): June 2, 2025
• Study Completion (Actual): July 2, 2025

Study Registration Dates

• First Submitted: September 2, 2024
• First Submitted That Met QC Criteria: September 3, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 18, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Ventilator-Induced Lung Injury; Bronchopulmonary Dysplasia; Anti-Bacterial Agents; Anti-Infective Agents; Azithromycin
• Other Study ID Numbers: 0201867

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No