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临床试验/NCT01156467
NCT01156467已完成不适用

Neurally Adjusted Ventilatory Assist (NAVA) in Ventilatory Care of Premature Infants

University of Oulu2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
The duration of mechanical ventilation

研究概览

简要总结

The purpose of this study is to find out, whether it is possible to improve the ventilatory care of premature infants by using Neurally adjusted ventilatory assist (NAVA).

The study hypothesis is that by using NAVA-technology and/or by monitoring Edi-signal (the electrical signal of diaphragm), it is possible to accomplish ventilatory care to premature infants more individually.

详细描述

Asynchrony means that the timing of support given by the ventilator is different from patients own breathing pattern. Asynchrony during ventilatory care may increase the risk for complications especially in premature infants with immature lungs.

In this study investigators will compare currently used ventilation methods to a new neurally adjusted ventilatory assist (NAVA). The aim is to find out, whether by using this new method it is possible to decrease the complications associated to ventilatory care and to shorten the need for mechanical ventilation.

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

年龄范围
— 至 9 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • All children of postconceptional age from 28+0 to 36+6 weeks needing mechanical ventilation for at least 60 minutes

排除标准

  • severe birth asphyxia, malformations, chromosomal abnormality or other condition, which will decrease the length of life
  • condition which prevents the positioning of an oro-/nasogastric tube

结局指标

主要结局

The duration of mechanical ventilation

时间窗: 1 hour - 6 weeks

次要结局

  • Complications associated to mechanical ventilation(1 hour - 6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Merja Ålander

MD

University of Oulu

研究点 (2)

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