Design of a Non-invasive Multi-modal Neonatal Monitoring System

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Design of a Non-invasive Multi-modal Neonatal Monitoring System: Preliminary Observational Study

Conditions
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Neonatal Disorder

Intervention / Treatment
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* Other: Data collection


Participation Criteria
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Eligibility Criteria
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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.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neonates<br>Babies born in Rennes University Hospital | Other: Data collection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the cardiac variability during the stay in the ward | 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. | Up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the respiratory variability during the stay in the ward | 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. | Up to 2 months | 
| Evolution of the babies' movements during the stay in the ward | Continuous video acquisitions of the newborns are realized. Video images will be analyzed by specific routines to extract quantitative parameters of movements. | Up to 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonates, non invasive monitoring