Efficacy of Clarithromycin Treatment in Prevention of Chronic Lung Disease in Premature Infants
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 273
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of clarithromycin in eradication of Ureaplasma urealyticum from premature nasopharynges
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of clarithromycin in eradication of ureaplasma urealyticum and prevention of chronic lung disease in premature infants with birthweight < 1250 g and have ureaplasma urealyticum colonization.
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
- Double (Care Provider, Investigator)
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
- •The babies under 1250 gram
- •The babies must be appropriate for gestational age
排除标准
- •Multiple congenital anomalies or known syndromes
- •Intrauterine growth retardation with birthweight less than 10 percentile for gestational age
研究组 & 干预措施
Clarithromycine Group: Active Comparator
Drug: Clarithromycin intravenous clarithromycin (10 mg/kg twice a day for 10 days)
干预措施: Clarithromycin (Drug)
Placebo Group: Placebo Comparator
Drug: D5W Dose given daily, IV same volume that Clarithromycin would be to equal 10 mg/kg for first 10 days.
干预措施: Dextrose (Drug)
结局指标
主要结局
To evaluate the efficacy of clarithromycin in eradication of Ureaplasma urealyticum from premature nasopharynges
时间窗: 12 days after treatment by clarithromycin
Efficacy of clarithromycin in eradication of Ureaplasma and incidence of CLD were the major outcomes of the study. Nasopharyngeal swabs for Ureaplasma were taken in postnatal first 3 days and on the 12th day only in culture positive infants, transported to the laboratory and cultured for Uu immediately.
次要结局
- To evaluate the efficacy of clarithromycin in prevention of Chronic lung disease in premature infants with birthweight <1250 g and have Ureaplasma urealyticum colonization.(From first day of inclusion of study to at postpartum 36th week of day)