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COMPLETED
NCT02863978
NA

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

Sponsor: Rennes University Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

Any - 6 Weeks

Study Type

INTERVENTIONAL

Enrollment

746

Start Date

2016-11-08

Completion Date

2026-01-21

Last Updated

2026-06-23

Healthy Volunteers

No

Interventions

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.

Locations (6)

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