Digi-NewB: Preliminary Study to the Conception of a Non-invasive Neonatal Monitoring System With Development of a Database
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
The database will be used to answer the following specific objectives, with priority given to the two first ones (sepsis and maturation) :
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Early diagnosis of sepsis for the following cases : Late onset sepsis of premature newborns, materno-fœtal sepsis, and newborn infection by chorioamnionitis
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Cardio-respiratory and neurobehavioral maturation (movements, sleeping cycles)
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Influence of environmental factors and developmental care on selected parameters
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Influence on care organisation of the possibility to access videos and movement analyses by medical teams
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Influence of glycemia on selected parameters
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Influence of neurological lesions and broncho-pulmonary dysplasia on selected parameters
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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)
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Evaluation of the acquisition system's user-friendliness
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Digi-NewB Cohort Multimodal signal acquisitions |
Other: Multimodal signal acquisitions
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.
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Outcome Measures
Primary Outcome Measures
- Number of newborns in neonatology unit [Four years]
Secondary Outcome Measures
- Infection/Sepsis [During the stay in neonatal unit, up to 10 weeks]
Identification of late onset sepsis of premature newborns, materno-fœtal sepsis, and newborn infection by chorioamnionitis
- Maturation [During the stay in neonatal unit, up to 10 weeks]
Quantification of maturation, i.e. evaluation of cardio respiratory rates and neurobehavioral maturation
- Influence of environment and developmental care [During the stay in neonatal unit, up to 10 weeks]
Measure of impact of access to new variables (maturation, rates) on care organisation and system's perception by families (Likert scales)
- Care givers satisfaction [Each 6 months after setting up the acquisition system in the unit]
Evaluation of carers' satisfaction with the new variables and the system's relevance in relation to their needs ("use cases" methods)
- Impact on newborn's time of quiet sleep [At the end of the stay in neonatal unit, up to 10 weeks]
Quantification of the relative time of quiet sleep
- Glycemia [During the stay in neonatal unit, up to 10 weeks]
Measures of physiological impact of hypo and hyperglycemias to assess the predictive value of hyperglycemia on sepsis risk
- Cerebral Electrophysiology [During the stay in neonatal unit, up to 10 weeks]
Compared evaluation of data coming from Digi-NewB cohort with available data from EEG and polysomnography (impact of cerebral damages, broncho-pulmonary dysplasia)
- Medium term Prognosis [During the stay in neonatal unit, up to 10 weeks]
Acquisition of magnetic resonance images (T1, T2, diffusion and cerebral perfusion arterial spin labeling) in neonatology
- Prognosis evaluation [At the babies 1st and 2nd birthdays]
Assessment of the baby's neuro-development by Ages & Stages Questionnaires® (ASQ) and health related events (hospitalisation, growth...)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Newborn hospitalised in the neonatology services of participating hospitals
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One of the legal representatives gave its signed agreement to take part to the study
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New born aged of less than 6 weeks in corrected term
Exclusion Criteria:
- No signed agreement from the legal representative
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brest University Hospital | Brest | Brittany | France | 29609 |
| 2 | Angers University Hospital | Angers | France | 49000 | |
| 3 | Nantes University Hospital | Nantes | France | 44000 | |
| 4 | Poitiers University Hospital | Poitiers | France | 86000 | |
| 5 | Rennes University Hospital | Rennes | France | 35000 | |
| 6 | Tours University Hospital | Tours | France | 37000 |
Sponsors and Collaborators
- Rennes University Hospital
- European Union
- GCS Hôpitaux Universitaires Grand-Ouest
- Rennes 1 University
- Tampere University of Technology
- Voxygen Health
- INESC TEC Porto
- National University of Ireland, Galway, Ireland
- Synchrophi Systems Ltd
Investigators
- Study Director: Patrick PLADYS, MD, PhD, CHU Rennes
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 35RC16_9714
- 2016-A00993-48