NCT06584474

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 7 Days – 28 Days
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-02
• Primary completion: 2025-06-02
• Completion: 2025-07-02
• First posted: 2024-09-04
• Last updated: 2025-07-20

Locations

2 sites across 1 country: Egypt