Xenon and Cooling Therapy in Babies at High Risk of Brain Injury Following Poor Condition at Birth: A Randomised Pilot Outcomes Study (COOLXENON3 Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Death and moderate or severe disability - Bayley III neurodevelopmental outcome score
研究概览
简要总结
This study examines the effect of inhaled xenon gas in the treatment of newborn infants with hypoxic-ischemic encephalopathy (HIE) in combination with cooling, which is the standard treatment for this condition. The hypothesis is that the xenon + cooling combination will produce better neuroprotection than the standard treatment of cooling alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
72h cooling + 18h xenon inhalation
Babies in poor condition at birth and referred to our neonatal unit for standard therapy of cooling to 33.5 degree C body temperature will be randomised to receive xenon gas at 50% concentration for 18 hours
干预措施: Xenon gas (Drug)
72h cooling + 18h xenon inhalation
Babies in poor condition at birth and referred to our neonatal unit for standard therapy of cooling to 33.5 degree C body temperature will be randomised to receive xenon gas at 50% concentration for 18 hours
干预措施: Whole body cooling (Other)
Standard 72 h whole body cooling therapy
Whole body cooling therapy to rectal temperature of 33.5 degree Centigrade (standard therapy)
干预措施: Whole body cooling (Other)
结局指标
主要结局
Death and moderate or severe disability - Bayley III neurodevelopmental outcome score
时间窗: 18 months of age
Cognition, language and motor scores, hearing and vision
次要结局
- Brain MRI(Before hospital discharge, within 2 weeks of birth)
- Amplitude Integrated Electroencephalogram (aEEG) grading(Before hospital discharge, usually within 1 week of birth)