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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00993-48 | Other Identifier | ID-RCB |
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| Name | Class |
|---|---|
| European Union | OTHER |
| GCS Hôpitaux Universitaires Grand-Ouest | UNKNOWN |
| University of Rennes | OTHER |
| Tampere University of Technology |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digi-NewB Cohort | Experimental | Multimodal signal acquisitions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal signal acquisitions | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of newborns in neonatology unit | Four years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick PLADYS, MD, PhD | Rennes University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brest University Hospital | Brest | Brittany Region | 29609 | France | ||
| Angers University Hospital |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| OTHER |
| Voxygen Health | UNKNOWN |
| INESC TEC Porto | UNKNOWN |
| National University of Ireland, Galway, Ireland | OTHER |
| Synchrophi Systems Ltd | UNKNOWN |
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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 |
| Angers |
| 49000 |
| France |
| Nantes University Hospital | Nantes | 44000 | France |
| Poitiers University Hospital | Poitiers | 86000 | France |
| Rennes University Hospital | Rennes | 35000 | France |
| Tours University Hospital | Tours | 37000 | France |
| D000091642 | Urogenital Diseases |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |