Status:
COMPLETED
THE EFFECT OF NEBULIZED AZITHROMYCIN AS THERAPY FOR BRONCHOPULMONARY DYSPLASIA
Lead Sponsor:
Alexandria University
Conditions:
Bronchopulmonary Dysplasia
Premature
Eligibility:
All Genders
7-28 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06584474
Start Date
October 2 2024
End Date
July 2 2025
Last Update
July 20 2025
Active Locations (2)
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1
Alexandria University
Alexandria, Egypt, 0325
2
Alexandria University
Alexandria, Egypt, 0356