THE EFFECT OF NEBULIZED AZITHROMYCIN AS… | Clinical Trial

Key information

Conditions

Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Premature Birth Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Urogenital Diseases Ventilation, Mechanical Ventilator-Induced Lung Injury

Age range

7 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alexandria University, Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

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.

Treatment and study plan

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

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.

Primary outcomes

Development of BPD (bronchopulmonary dysplasia)

Time frame: 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.
Lung Ultrasound assessment

Time frame: 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
- 3 or more nonconfluent B lines
- confluent B lines
- C profile or consolidation

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Sep 4, 2024
Registry last updated: Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed