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Avoiding Hypotension in Preterm Neonates (AHIP)

2017年1月16日更新者：Pichler Gerhard, MD.、Medical University of Graz

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

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.

研究概览

地位

完全的

条件

低血压

干预/治疗

研究类型

介入性

注册 (实际的)

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

奥地利
- Styria
  - Graz、Styria、奥地利、8036
    - Dep. of Pediatrics, Medical University of Graz

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

不超过 6小时 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

preterm neonates
decision to conduct full life support
written informed consent
age <6 hours
no use of catecholamines before start of NIRS measurements

Exclusion Criteria:

no decision to conduct full life support
no written informed consent
age >6 hours
use of catecholamines before start of NIRS measurements
congenital malformation

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：预防
分配：随机化
介入模型：并行分配
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：NIRS visible and predefined interventions NIRS measurements are visible and the patients will be treated according to predefined clinical interventions: If cTOI/pTOI ratio increases >5% within a six-hours-period echocardiography will be performed and based on results of echocardiography and blood pressure a volume bolus or, if ventilated, modification of ventilation or treatment of patent ductus arteriosus will be considered.	设备：NIRS visible and predefined interventions NIRS measurements are visible and the patients will be treated according to predefined clinical interventions: If cTOI/pTOI ratio increases >5% within a six-hours-period echocardiography will be performed and based on results of echocardiography and blood pressure a volume bolus or, if ventilated, modification of ventilation or treatment of patent ductus arteriosus will be considered.
其他：NIRS not visible and treatment as usual NIRS measurements are not visible and the patients will be treated according to routine ('treatment as usual')	设备：NIRS not visible and treatment as usual NIRS not visible and the patients will be treated according to routine

参与者组/臂

干预/治疗

实验性的：NIRS visible and predefined interventions

NIRS measurements are visible and the patients will be treated according to predefined clinical interventions: If cTOI/pTOI ratio increases >5% within a six-hours-period echocardiography will be performed and based on results of echocardiography and blood pressure a volume bolus or, if ventilated, modification of ventilation or treatment of patent ductus arteriosus will be considered.

设备：NIRS visible and predefined interventions

其他：NIRS not visible and treatment as usual

NIRS measurements are not visible and the patients will be treated according to routine ('treatment as usual')

设备：NIRS not visible and treatment as usual

NIRS not visible and the patients will be treated according to routine

研究衡量的是什么？

主要结果指标

结果测量	大体时间
Time (percentage of hours) of hypotension/use of catecholamines during the first 48 hours 大体时间：48 hours	48 hours

次要结果测量

结果测量	措施说明	大体时间
Cerebral injury by cerebral ultrasound 大体时间：up to 16 weeks	From date of randomization until the date of discharge or date of 40 weeks of gestational age, whichever came first, assessed up to 16 weeks.	up to 16 weeks
Mortality 大体时间：up to 16 weeks		up to 16 weeks

其他结果措施

结果测量	措施说明	大体时间
Neonatal morbidities 大体时间：up to 16 weeks	From date of randomization until the date of discharge or date of 40 weeks of gestational age, whichever came first, assessed up to 16 weeks.	up to 16 weeks
Heart rate 大体时间：48 hours		48 hours
Blood pressure 大体时间：48 hours		48 hours
Arterial oxygen saturation 大体时间：48 hours		48 hours

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Medical University of Graz

调查人员

首席研究员：Gerhard Pichler, MD、Dep. of Pediatrics, Medical University of Graz

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年11月1日

初级完成 (实际的)

2016年12月1日

研究完成 (实际的)

2016年12月1日

研究注册日期

首次提交

2013年7月19日

首先提交符合 QC 标准的

2013年7月25日

首次发布 (估计)

2013年7月29日

研究记录更新

最后更新发布 (估计)

2017年1月18日

上次提交的符合 QC 标准的更新

2017年1月16日

最后验证

2017年1月1日

Avoiding Hypotension in Preterm Neonates (AHIP)