Preliminary Study to the Conception of a Non-invasive Neonatal Monitoring System With Development of a Database

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Preliminary Study to the Conception of a Non-invasive Neonatal Monitoring System With Development of a Database

Conditions
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Infant, Premature

Intervention / Treatment
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* Other: Multimodal signal acquisitions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: No signed agreement from the legal representative

Ages Eligible for Study
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Maximum Age: 6 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digi-NewB Cohort<br>Multimodal signal acquisitions | Other: Multimodal signal acquisitions<br>* Cardiac and respiratory signals are collected from the clinical monitoring routinely gathered in hospital neonatal units. Movement quantification and baby's sounds are extracted thanks to a dedicated system which will collect images and sound with microphones and cameras.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of newborns in neonatology unit |  | Four years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection/Sepsis | Identification of late onset sepsis of premature newborns, materno-fœtal sepsis, and newborn infection by chorioamnionitis | During the stay in neonatal unit, up to 10 weeks | 
| Maturation | Quantification of maturation, i.e. evaluation of cardio respiratory rates and neurobehavioral maturation | During the stay in neonatal unit, up to 10 weeks | 
| Influence of environment and developmental care | Measure of impact of access to new variables (maturation, rates) on care organisation and system's perception by families (Likert scales) | During the stay in neonatal unit, up to 10 weeks | 
| Care givers satisfaction | Evaluation of carers' satisfaction with the new variables and the system's relevance in relation to their needs (use cases methods) | Each 6 months after setting up the acquisition system in the unit | 
| Impact on newborn's time of quiet sleep | Quantification of the relative time of quiet sleep | At the end of the stay in neonatal unit, up to 10 weeks | 
| Glycemia | Measures of physiological impact of hypo and hyperglycemias to assess the predictive value of hyperglycemia on sepsis risk | During the stay in neonatal unit, up to 10 weeks | 
| Cerebral Electrophysiology | Compared evaluation of data coming from Digi-NewB cohort with available data from EEG and polysomnography (impact of cerebral damages, broncho-pulmonary dysplasia) | During the stay in neonatal unit, up to 10 weeks | 
| Medium term Prognosis | Acquisition of magnetic resonance images (T1, T2, diffusion and cerebral perfusion arterial spin labeling) in neonatology | During the stay in neonatal unit, up to 10 weeks | 
| Prognosis evaluation | Assessment of the baby's neuro-development by Ages & Stages Questionnaires® (ASQ) and health related events (hospitalisation, growth...) | At the babies 1st and 2nd birthdays | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardio-respiratory maturation, Neurobehavioral maturation, Sepsis, Neonates