Design of a Non-invasive Multi-modal Neonatal Monitoring System (VARI-NEONAT)
Design of a Non-invasive Multi-modal Neonatal Monitoring System: Preliminary Observational Study
研究概览
详细说明
300 000 newborns per year are hospitalized in European neonatal units in the post-natal period. This is a critical period for neurobehavioral development and the establishment of an optimal model of sleep-wake cycle is fundamental for brain development.
The objective of the research is to develop new tools for computer-aided clinical and predictive diagnosis and real-time monitoring in neonatology.
The development of non-invasive sensors based on video and sound images aims to improve the short- and medium-term prognosis in perinatal patients.
To that aim, multi-modal composite indices integrating the image (which is used only to generate a quantification of the movement) and the sound to the bioelectric signals already available (electrocardiogram, oxymetry, temperature) will be developed to provide diagnostic and prognostic information.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Rennes、法国、35000
- Rennes University hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- newborns less than 6 weeks old in corrected terms;
newborns in one of the following situations:
- persistent discomfort (apneas);
- infection or suspicion of infection;
- premature with uncomplicated evolution;
- Premature brain lesion acquired in perinatal;
- newborn having been exposed to premature rupture of the membranes.
Exclusion Criteria:
- Congenital malformation;
- Metabolic disease.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Neonates
Babies born in Rennes University Hospital
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After parental information and collection of their non-opposition, the data of the daily cardio-respiratory recordings of the newborns hospitalized in the units of Neonatology are collected and analyzed. At the same time, a video recording is set up. This video recording does not modify the care provided for the child, the organization of the day with nursing and parental care. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evolution of the cardiac variability during the stay in the ward
大体时间：Up to 2 months
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The cardiac signals collected by the clinical monitoring required for hospitalization in a neonatal unit will be analyzed by specific routines to calculate parameters of cardiac variability.
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Up to 2 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evolution of the respiratory variability during the stay in the ward
大体时间：Up to 2 months
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The respiratory signals collected by the clinical monitoring required for hospitalization in a neonatal unit will be analyzed by specific routines to calculate parameters of respiratory variability.
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Up to 2 months
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Evolution of the babies' movements during the stay in the ward
大体时间：Up to 2 months
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Continuous video acquisitions of the newborns are realized.
Video images will be analyzed by specific routines to extract quantitative parameters of movements.
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Up to 2 months
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合作者和调查者
调查人员
- 研究主任：Patrick PLADYS, MD, PhD、CHU Rennes
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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