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

Not Applicable

Active, not recruiting

• Conditions: Infant, Premature
• Interventions: Other: Multimodal signal acquisitions

• Registration Number: NCT02863978
• Lead Sponsor: Rennes University Hospital

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.

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 Timeline

• Study First Submitted: 2016-08-03
• Study First Submitted QC: 2016-08-08
• Study First Posted: 2016-08-11
• Study Start: 2016-11-08
• Primary Completion: 2020-06-10
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-13
• Last Update Posted: 2022-12-14
• Study Completion: 2024-06-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 746

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Digi-NewB Cohort	Multimodal signal acquisitions	Multimodal signal acquisitions

Primary Outcome Measures

Name	Time	Method
Number of newborns in neonatology unit	Four years

Secondary Outcome Measures

Name	Time	Method
Care givers satisfaction	Each 6 months after setting up the acquisition system in the unit	Evaluation of carers' satisfaction with the new variables and the system's relevance in relation to their needs ("use cases" methods)
Influence of environment and developmental care	During the stay in neonatal unit, up to 10 weeks	Measure of impact of access to new variables (maturation, rates) on care organisation and system's perception by families (Likert scales)
Maturation	During the stay in neonatal unit, up to 10 weeks	Quantification of maturation, i.e. evaluation of cardio respiratory rates and neurobehavioral maturation
Glycemia	During the stay in neonatal unit, up to 10 weeks	Measures of physiological impact of hypo and hyperglycemias to assess the predictive value of hyperglycemia on sepsis risk
Medium term Prognosis	During the stay in neonatal unit, up to 10 weeks	Acquisition of magnetic resonance images (T1, T2, diffusion and cerebral perfusion arterial spin labeling) in neonatology
Infection/Sepsis	During the stay in neonatal unit, up to 10 weeks	Identification of late onset sepsis of premature newborns, materno-fœtal sepsis, and newborn infection by chorioamnionitis
Impact on newborn's time of quiet sleep	At the end of the stay in neonatal unit, up to 10 weeks	Quantification of the relative time of quiet sleep
Prognosis evaluation	At the babies 1st and 2nd birthdays	Assessment of the baby's neuro-development by Ages \& Stages Questionnaires® (ASQ) and health related events (hospitalisation, growth...)
Cerebral Electrophysiology	During the stay in neonatal unit, up to 10 weeks	Compared evaluation of data coming from Digi-NewB cohort with available data from EEG and polysomnography (impact of cerebral damages, broncho-pulmonary dysplasia)

Trial Locations

Locations (6)

Angers University Hospital; 🇫🇷 Angers, France

Brest University Hospital; 🇫🇷 Brest, Brittany, France

Nantes University Hospital; 🇫🇷 Nantes, France

Poitiers University Hospital; 🇫🇷 Poitiers, France

Rennes University Hospital; 🇫🇷 Rennes, France

Tours University Hospital; 🇫🇷 Tours, France