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

Rennes University Hospital

Status: Active, not recruiting

Conditions: Infant, Premature

Treatments: Other: Multimodal signal acquisitions

Study type: Interventional

Funder types: Other

Identifiers

NCT02863978

2016-A00993-48 (Other Identifier)

35RC16_9714

Details and patient eligibility

About

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.

Full 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

Enrollment: 746 patients

Sex: All

Ages: Under 6 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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746 participants in 1 patient group

Digi-NewB Cohort

Experimental group

Description:

Multimodal signal acquisitions

Treatment:

Other: Multimodal signal acquisitions