Preliminary Study to the Conception of a Non-invasive Neonatal Monitoring System With Development of a Database
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 746
- 试验地点
- 12
- 主要终点
- Number of newborns in neonatology unit
研究概览
简要总结
Each year, 300 000 new borns are hospitalised in neonatology units in Europe. This period is very sensitive as newborns are exposed to a high risk of morbidity and mortality, with severe impact on neuro-developmental prognostic. The Rennes University Hospital was granted a specific funding from the European Union in the framework of the Horizon 2020 programme (Call PERSONALISING HEALTH AND CARE 2015-single-stage - Grant Agreement Number 689260) to develop the Digi-NewB project. This project aims to develop innovative non-invasive monitoring tools to support decision making in health. Such tools include a new generation of real time monitoring in neonatology using composite indices made of cardio-respiratory variables, movements, sounds, and clinical data. The Digi-NewB cohort aims to gather all physiological data relevant for the creation of the composite indices.
详细描述
The database will be used to answer the following specific objectives, with priority given to the two first ones (sepsis and maturation) :
- Early diagnosis of sepsis for the following cases : Late onset sepsis of premature newborns, materno-fœtal sepsis, and newborn infection by chorioamnionitis
- Cardio-respiratory and neurobehavioral maturation (movements, sleeping cycles)
- Influence of environmental factors and developmental care on selected parameters
- Influence on care organisation of the possibility to access videos and movement analyses by medical teams
- Influence of glycemia on selected parameters
- Influence of neurological lesions and broncho-pulmonary dysplasia on selected parameters
- Indices correlation with medical images MRI (T1, T2, diffusion, Arterial Spin Labelling) from neonatal units and with health evaluated after 1 and 2 years with the Ages & Stages Questionnaires (ASQ)
- Evaluation of the acquisition system's user-friendliness
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Newborn hospitalised in the neonatology services of participating hospitals
- •One of the legal representatives gave its signed agreement to take part to the study
- •New born aged of less than 6 weeks in corrected term
排除标准
- •No signed agreement from the legal representative
研究组 & 干预措施
Digi-NewB Cohort
Multimodal signal acquisitions
干预措施: Multimodal signal acquisitions (Other)
结局指标
主要结局
Number of newborns in neonatology unit
时间窗: Four years
次要结局
- Maturation(During the stay in neonatal unit, up to 10 weeks)
- Influence of environment and developmental care(During the stay in neonatal unit, up to 10 weeks)
- Glycemia(During the stay in neonatal unit, up to 10 weeks)
- Medium term Prognosis(During the stay in neonatal unit, up to 10 weeks)
- Infection/Sepsis(During the stay in neonatal unit, up to 10 weeks)
- Care givers satisfaction(Each 6 months after setting up the acquisition system in the unit)
- Impact on newborn's time of quiet sleep(At the end of the stay in neonatal unit, up to 10 weeks)
- Prognosis evaluation(At the babies 1st and 2nd birthdays)
- Cerebral Electrophysiology(During the stay in neonatal unit, up to 10 weeks)