NCT02863978

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
746

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 8, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2020

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2024

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

3.6 years

First QC Date

August 3, 2016

Last Update Submit

December 13, 2022

Conditions

Infant, Premature

Keywords

SepsisNeonatesCardio-respiratory maturationNeurobehavioral maturation

Outcome Measures

Primary Outcomes (1)

  • Number of newborns in neonatology unit

    Four years

Secondary Outcomes (9)

  • Infection/Sepsis

    During the stay in neonatal unit, up to 10 weeks

  • Maturation

    During the stay in neonatal unit, up to 10 weeks

  • Influence of environment and developmental care

    During the stay in neonatal unit, up to 10 weeks

  • Care givers satisfaction

    Each 6 months after setting up the acquisition system in the unit

  • Impact on newborn's time of quiet sleep

    At the end of the stay in neonatal unit, up to 10 weeks

  • +4 more secondary outcomes

Study Arms (1)

Digi-NewB Cohort

EXPERIMENTAL

Multimodal signal acquisitions

Other: Multimodal signal acquisitions

Interventions

Multimodal signal acquisitionsOTHER

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.

Digi-NewB Cohort

Eligibility Criteria

AgeUp to 6 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Newborn hospitalised in the neonatology services of participating hospitals
  • 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

You may not qualify if:

  • No signed agreement from the legal representative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Brest University Hospital

Brest, Brittany Region, 29609, France

Location

Angers University Hospital

Angers, 49000, France

Location

Nantes University Hospital

Nantes, 44000, France

Location

Poitiers University Hospital

Poitiers, 86000, France

Location

Rennes University Hospital

Rennes, 35000, France

Location

Tours University Hospital

Tours, 37000, France

Location

Related Links

MeSH Terms

Conditions

Premature BirthSepsis

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Patrick PLADYS, MD, PhD

    CHU Rennes

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2016

First Posted

August 11, 2016

Study Start

November 8, 2016

Primary Completion

June 10, 2020

Study Completion

June 10, 2024

Last Updated

December 14, 2022

Record last verified: 2022-12

Locations

FR(6)