Prophylaxis of Bronchopulmonary Dysplasia With Clarithromycin
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Bronchopulmonary dysplasia
研究概览
简要总结
The purpose of this study is to determine of clarithromycin effect on developing of bronchopulmonary dysplasia in preterm babies.
详细描述
The investigators planned that clarithromycin treatment in preterm babies who are under 1250 grams birth weight.
The investigators aimed with this treatment, the bronchopulmonary dysplasia rate of preterm babies may decrease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 1 Hour 至 2 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all infant must be under 1250 gram birth weight
排除标准
- •Major congenital anomaly,
- •CardiaC abnormality,
- •without inform consent
研究组 & 干预措施
Clarithromycin
Fist group treated with clarithromycin which is include 10 days application.
干预措施: clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia (Drug)
placebo
Second group treated with salin as same as amount of clarithromycine volume
干预措施: Saline (Drug)
结局指标
主要结局
Bronchopulmonary dysplasia
时间窗: 28. day of birth
On the 28. day of birth, The investigator will determine the baby whether has developed bronchopulmonary dysplasia
次要结局
- Overall survival(Participants will be followed for the duration of hospital stay, an expected average of postnatal 40 weeks)
研究者
Sadik Yurttutan
Fellowship of neonatology
Zekai Tahir Burak Women's Health Research and Education Hospital