Preliminary Study to the Conception of a Non-invasive Neonatal Monitoring System With Development of a Database
NCT ID: NCT02863978
Last Updated: 2022-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
746 participants
INTERVENTIONAL
2016-11-08
2024-06-10
Brief Summary
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Detailed Description
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1. Early diagnosis of sepsis for the following cases : Late onset sepsis of premature newborns, materno-fœtal sepsis, and newborn infection by chorioamnionitis
2. Cardio-respiratory and neurobehavioral maturation (movements, sleeping cycles)
3. Influence of environmental factors and developmental care on selected parameters
4. Influence on care organisation of the possibility to access videos and movement analyses by medical teams
5. Influence of glycemia on selected parameters
6. Influence of neurological lesions and broncho-pulmonary dysplasia on selected parameters
7. 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)
8. Evaluation of the acquisition system's user-friendliness
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Digi-NewB Cohort
Multimodal signal acquisitions
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
6 Weeks
ALL
No
Sponsors
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European Union
OTHER
GCS Hôpitaux Universitaires Grand-Ouest
UNKNOWN
Rennes 1 University
UNKNOWN
Tampere University of Technology
OTHER
Voxygen Health
UNKNOWN
INESC TEC Porto
UNKNOWN
National University of Ireland, Galway, Ireland
OTHER
Synchrophi Systems Ltd
UNKNOWN
Rennes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Patrick PLADYS, MD, PhD
Role: STUDY_DIRECTOR
CHU Rennes
Locations
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Brest University Hospital
Brest, Brittany Region, France
Angers University Hospital
Angers, , France
Nantes University Hospital
Nantes, , France
Poitiers University Hospital
Poitiers, , France
Rennes University Hospital
Rennes, , France
Tours University Hospital
Tours, , France
Countries
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Related Links
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Related Info
Other Identifiers
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2016-A00993-48
Identifier Type: OTHER
Identifier Source: secondary_id
35RC16_9714
Identifier Type: -
Identifier Source: org_study_id