The Efect of Azithromicyn on Bronchopulmonary Displasia in Extremely Preterm and Very Preterm Infant
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Bronchopulmonaty Dysplasia
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •premature infant 25-31 weeks 6 days with respiratory distress,
排除标准
- •multiple congenital anomaly
研究组 & 干预措施
Intervention group
Intervention group will give azithromycin for 14 days, 7 days 10 mg/body weight/24 hours, 7 days 5 mg/bw/hours
干预措施: Azithromycin Powder (Drug)
结局指标
主要结局
Bronchopulmonaty Dysplasia
时间窗: 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
次要结局
- Intraventricular hemorrhage(1 days-7 days, and 6 weeks)
- Necrotizing Enterocolitis(1 days-36 weeks PMA)
研究者
Besse Sarmila
dr. Besse Sarmila, Sp.A, trainee subspecialist neonatology division, principle investigator, clinicalpediatrician
Indonesia University