NCT02863978

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 746 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 6 Weeks
• Healthy volunteers: Not accepted

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

Conditions

• Infant, Premature

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-11-08
• Primary completion: 2020-06-10
• Completion: 2024-06-10
• First posted: 2016-08-11
• Last updated: 2022-12-14

Locations

6 sites across 1 country: France