The Efect of Azithromicyn on Bronchopulmonary Displasia in Extremely Preterm and Very Preterm Infant
Overview
- Phase
- Phase 4
- Intervention
- Azithromycin Powder
- Conditions
- Bronchopulmonary Dysplasia
- Sponsor
- Indonesia University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Bronchopulmonaty Dysplasia
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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
Investigators
Besse Sarmila
dr. Besse Sarmila, Sp.A, trainee subspecialist neonatology division, principle investigator, clinicalpediatrician
Indonesia University
Eligibility Criteria
Inclusion Criteria
- •premature infant 25-31 weeks 6 days with respiratory distress,
Exclusion Criteria
- •multiple congenital anomaly
Arms & Interventions
Intervention group
Intervention group will give azithromycin for 14 days, 7 days 10 mg/body weight/24 hours, 7 days 5 mg/bw/hours
Intervention: Azithromycin Powder
Outcomes
Primary Outcomes
Bronchopulmonaty Dysplasia
Time Frame: 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
Use of oxygen suplemantation at least 28 days until 36 weeks PMA
Secondary Outcomes
- Intraventricular hemorrhage(1 days-7 days, and 6 weeks)
- Necrotizing Enterocolitis(1 days-36 weeks PMA)