THE EFFECT OF NEBULIZED AZITHROMYCIN AS THERAPY FOR BRONCHOPULMONARY DYSPLASIA

PHASE4CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

October 2, 2024

Primary Completion Date

June 2, 2025

Study Completion Date

July 2, 2025

Conditions
Bronchopulmonary DysplasiaPrematureVentilation, Mechanical
Interventions
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.

Trial Locations (2)

0325

Alexandria University, Alexandria

0356

Alexandria University, Alexandria

All Listed Sponsors
lead

Alexandria University

OTHER

NCT06584474 - THE EFFECT OF NEBULIZED AZITHROMYCIN AS THERAPY FOR BRONCHOPULMONARY DYSPLASIA | Biotech Hunter | Biotech Hunter