Physiological responses to intravenous caffeine in neonates with Hypoxic Ischaemic Encephalopathy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in cerebral oxygenation pre and post caffeine administration
研究概览
简要总结
Administration of intravenous caffeine in babies with moderate to severe encephalopathy will be done along with calculation of cerebral oxygenation before and after giving intravenous caffeine.
Besides this, electroencephalography, cerebral dopplers, heart rate variability and pain scores will be calculated before and after giving caffeine.
This caffeine dose will be administered intravenously between 24 to 48 hours of life and an MRI will be done at days 9 to 14 of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Day(s) 至 30.00 Day(s)（—）
- 性别
- All
入选标准
- •All male and female newborns with hypoxic ischemic encephalopathy till 30 days of life.
排除标准
- •No sex is excluded.
- •Age beyond 30 days is excluded.
结局指标
主要结局
Change in cerebral oxygenation pre and post caffeine administration
时间窗: Change in cerebral oxygenation pre and post caffeine administration between 36 to 50 hours of life only. | Baseline 2 hours before administering caffeine and second 2 hours after administering caffeine
次要结局
- Change in renal and Splanchnic oxygenation index pre and post caffeine administration(Change in Cerebral, mesenteric, celiac artery doppler pre and post caffeine administration)
研究者
Reema Garegrat
Perinatal Brain Research Centre and Gupta Neonatal Hospital