Design of a Non-invasive Multi-modal Neonatal Monitoring System: Preliminary Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Evolution of the cardiac variability during the stay in the ward
研究概览
简要总结
This is a preliminary study whose objectives are to define the clinical use cases and the constraints of the implementation of a multi-sensor image-sound system.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 6 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Congenital malformation;
- •Metabolic disease.
结局指标
主要结局
Evolution of the cardiac variability during the stay in the ward
时间窗: Up to 2 months
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.
次要结局
- Evolution of the respiratory variability during the stay in the ward(Up to 2 months)
- Evolution of the babies' movements during the stay in the ward(Up to 2 months)