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

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.

Conditions

• Infant, Premature

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.

Sponsors & Collaborators

• European Union

  collaborator OTHER

• GCS Hôpitaux Universitaires Grand-Ouest

  collaborator UNKNOWN

• Rennes 1 University

  collaborator UNKNOWN

• Tampere University of Technology

  collaborator OTHER

• Voxygen Health

  collaborator UNKNOWN

• INESC TEC Porto

  collaborator UNKNOWN

• National University of Ireland, Galway, Ireland

  collaborator OTHER

• Synchrophi Systems Ltd

  collaborator UNKNOWN

• Rennes University Hospital

  lead OTHER

Principal Investigators

• Patrick PLADYS, MD, PhD · CHU Rennes

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

6 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-11-08

Primary Completion

2020-06-10

Completion

2024-06-10

Countries

• France

Study Locations