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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Infant, Premature
• Intervention / Treatment: Other: Multimodal signal acquisitions

Detailed Description

The database will be used to answer the following specific objectives, with priority given to the two first ones (sepsis and maturation) :

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

• Study Type: Interventional
• Enrollment (Actual): 746
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49000
    • Angers University Hospital
  • Nantes, France, 44000
    • Nantes University Hospital
  • Poitiers, France, 86000
    • Poitiers University Hospital
  • Rennes, France, 35000
    • Rennes University Hospital
  • Tours, France, 37000
    • Tours University Hospital
  • Brittany
    • Brest, Brittany, France, 29609
      • Brest University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• No signed agreement from the legal representative

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digi-NewB Cohort; Multimodal signal acquisitions	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of newborns in neonatology unit	Four years

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Collaborators: National University of Ireland, Galway, Ireland; European Union; Tampere University of Technology; GCS Hôpitaux Universitaires Grand-Ouest; Rennes 1 University; Voxygen Health; INESC TEC Porto; Synchrophi Systems Ltd
• Investigators: Study Director: Patrick PLADYS, MD, PhD, Chu Rennes

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2016
• Primary Completion (Actual): June 10, 2020
• Study Completion (Anticipated): June 10, 2024

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: August 8, 2016
• First Posted (Estimate): August 11, 2016

Study Record Updates

• Last Update Posted (Actual): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Sepsis; Neonates; Cardio-respiratory maturation; Neurobehavioral maturation
• Other Study ID Numbers: 35RC16_9714; 2016-A00993-48 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided