CTRI/2009/091/000041未知4 期
A Randomized Controlled Trial comparing Indomethacin vs. No treatment for PDA on the basis of Size in the first 24 hrs of life in Preterm babies between 28 to 32 weeks gestation requiring Assisted Ventilation
Anil Batra1 个研究点 分布在 1 个国家目标入组 0 人开始时间: 待定
试验速览
- 阶段
- 4 期
- 发起方
- 试验地点
- 1
- 主要终点
- Closure of PDA at 7 days of life
研究概览
简要总结
This study is a randomized controlled trial comparing indomethacin vs no treatment for PDA on the basis of size in first 24 hrs of life in preterm ventilated babies requiring ventilatory support. this study is being conducted in a tertiary level NICU of Sir Ganga Ram Hospital in New Delhi. the primary outcome measure will be PDA closure at 7 days of age. The secondary outcome measures will include Duration of assisted ventilation, Hemodynamically significant PDA at 3 days of age, Pulmonary hemorrhage,Intraventricular haemorrhage, Duration of oxygen dependence, Duration of hospital stay,Sepsis and the side effects related to indomethacin.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
入选标准
- •32 weeks admitted to NICU within 12 hrs of birth Ventilatory support for respiratory distress PDA more than or equal to 2 mm in size in the first 24 hrs of life.
排除标准
- •Babies with major congenital malformations Any contraindication of giving indomethacinBabies with severe asphyxia as defined by Apgar score, <3 at 5 min of life with cord/with in 1 hour of life pH< 7.0 or base excess >16Shock requiring pressor support at time of randomizationRefusal to obtain consentGestation below 28 weeksPresence of other cardiac malformations including ASD, VSD, any cause of left ventricular dysfunction and mitral valve abnormalities.
结局指标
主要结局
Closure of PDA at 7 days of life
时间窗: 7 days
次要结局
- Duration of assisted ventilation Hemodynamically significant PDA at 3 days of agePulmonary hemorrhageIntraventricular haemorrhage Duration of oxygen dependence Duration of hospital staySepsis Side effects related to indomethacin(3 daysNursery stay)
研究者
研究点 (1)
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