Avoiding Hypotension in Preterm Neonates (AHIP) - A Randomised Controlled Study on Near Infrared Spectroscopy Monitoring of Peripheral-muscle and Cerebral Oxygenation With Defined Interventions Versus Routine Monitoring and Treatment in Preterm Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Time (percentage of hours) of hypotension/use of catecholamines during the first 48 hours
研究概览
简要总结
Objectives Firstly to examine in preterm neonates, whether it is possible to reduce number of hypotensive episodes and use of catecholamines by applying cerebral/peripheral near infrared spectroscopy in combination with predefined interventions and secondly to explore the potential impact on cerebral injury and mortality.
Hypothesis By using predefined interventions for changes in cerebral/peripheral oxygenation ratio investigators will reduce hypotensive episodes and use of catecholamines which will reduce cerebral injury and mortality.
Methods Cerebral (cTOI) and peripheral-muscle (pTOI) tissue-oxygenation-index (NIRO 300) will be measured for 24h starting <6 hours postpartum. When cTOI/pTOI ratio increases >5% within a 6h period, predefined interventions will be performed.
Primary outcome parameter will be duration of hypotensive episodes and use of catecholamines during the first 48h after birth. Secondary outcome parameters will be cerebral injury and mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 6 Hours(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm neonates
- •decision to conduct full life support
- •written informed consent
- •age <6 hours
- •no use of catecholamines before start of NIRS measurements
排除标准
- •no decision to conduct full life support
- •no written informed consent
- •age >6 hours
- •use of catecholamines before start of NIRS measurements
- •congenital malformation
结局指标
主要结局
Time (percentage of hours) of hypotension/use of catecholamines during the first 48 hours
时间窗: 48 hours
次要结局
- Cerebral injury by cerebral ultrasound(up to 16 weeks)
- Mortality(up to 16 weeks)
研究者
Pichler Gerhard, MD.
Ass. Prof. Dr.
Medical University of Graz
