NCT05223790招募中不适用
Assessment of the NIPE in Very Premature Infant Ventilated and Sedated in Neonatal Reanimation.
University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年3月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Variation of the NIPE measures between before and during care.
研究概览
简要总结
The Newborn Infant Parasympathetic Evaluation (NIPE) was developed as a method of analysis of the heart rate variability. The monitor gives a value between 0 (low value of the parasympathetic component) and 100 (high value of the parasympathetic component).
So far, the measure of the heart failure variability by using the NIPE in infant born very premature ventilated and sedated in neonatal reanimation has not been realised and validated as an evaluation method of the pain and discomfort related to neonatal care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Days 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant born very premature before 34 weeks of amenorrhoea + 0 day
- •Age ≤ 7 days
- •Admitted in neonatal reanimation
- •Sedated, intubated, ventilated
排除标准
- •High frequency oscillation ventilation
- •Heart rate non sinusal
- •Inotropes and atropine
- •Opposition from the guardian of parental authority
- •Difficulty of comprehension or communication making the parental information impossible
结局指标
主要结局
Variation of the NIPE measures between before and during care.
时间窗: From 10 minutes before the care to 10 minutes after the beginning of the care
Average of NIPE mesures 10 minutes before the begining of the care and 10 minutes after.
次要结局
- The discriminant power of the NIPE to split the painful population and the non-painful population determined by a threshold at 6 on the PIPP-R scale(From 10 minutes before the care to 10 minutes after the care)
- Correlation between the variation of the NIPE measures and the variation of PIPP-R behavioural scale between each period(From 10 minutes after the beginning of the care to 10 minutes after the end of the care)
- Correlation between the NIPEmin and the PIPP-R behavioural scale for each period(From 10 minutes before the care to 10 minutes after the care)
研究者
研究点 (1)
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