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临床试验/NCT01910467
NCT01910467已完成不适用

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

Medical University of Graz2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2013年11月1日最近更新:
适应症

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

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

发起方
Medical University of Graz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pichler Gerhard, MD.

Ass. Prof. Dr.

Medical University of Graz

研究点 (2)

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