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Clinical trial

The Efect of Azithromicyn on Bronchopulmonary Displasia in Extremely Preterm and Very Preterm Infant

ID
Name
21050544
Description
This study was to see the effectiveness of azithromycin in preventing the incidence of bronchopulmonary dysphasia in extremely preterm and very premature infants. Inclusion criteria were infants with a gestational age of 25-31 weeks 6 days who experienced respiratory distress and their families had agreed to participate in the study, then randomized. The intervention was in the form of giving azithromycin in the intervention group and no intervention was carried out in the control group and then followed up to 36 weeks PMA
Trial arms
Trial start
2021-06-08
Estimated PCD
2022-03-01
Trial end
2022-04-01
Status
Completed
Phase
Early phase I
Treatment
Azithromycin Powder
Azithromicyn intravena for 14 days
Arms:
Intervention group
Size
120
Primary endpoint
Bronchopulmonaty Dysplasia
BPD mild room air until 36 weeks PMA, BPD moderate use of oxygen <30% until 36 weeks PMA, BPD severe use of oxygen >30% until 36 weeks PMA
Eligibility criteria
Inclusion Criteria: * premature infant 25-31 weeks 6 days with respiratory distress, Exclusion Criteria: * multiple congenital anomaly
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups, one group intervention and one group control', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ACTUAL'}}
Updated at
2024-03-08

1 organization

1 product

3 indications

Organization
Indonesia University
Product
Azithromycin
Indication
Bronchopulmonary Dysplasia
Indication
Intraventricular Hemorrhage
Indication
Necrotizing enterocolitis