Clinical trial NCT02863978: Preliminary Study to the Conception of a Non-invasive Neonatal Monitoring System With Development of a Database
Official title: Preliminary Study to the Conception of a Non-invasive Neonatal Monitoring System With Development of a Database
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infant, Premature
Keywords: Sepsis
Neonates
Cardio-respiratory maturation
Neurobehavioral maturation
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: European Union
name: GCS Hôpitaux Universitaires Grand-Ouest
name: Rennes 1 University
name: Tampere University of Technology
name: Voxygen Health
name: INESC TEC Porto
name: National University of Ireland, Galway, Ireland
name: Synchrophi Systems Ltd
First posted: 2016-08-11
Enrollment: 746
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of newborns in neonatology unit
timeFrame: Four years
Secondary outcomes:
measure: Infection/Sepsis
timeFrame: During the stay in neonatal unit, up to 10 weeks
measure: Maturation
timeFrame: During the stay in neonatal unit, up to 10 weeks
measure: Influence of environment and developmental care
timeFrame: During the stay in neonatal unit, up to 10 weeks
measure: Care givers satisfaction
timeFrame: Each 6 months after setting up the acquisition system in the unit
measure: Impact on newborn's time of quiet sleep
timeFrame: At the end of the stay in neonatal unit, up to 10 weeks
measure: Glycemia
timeFrame: During the stay in neonatal unit, up to 10 weeks
measure: Cerebral Electrophysiology
timeFrame: During the stay in neonatal unit, up to 10 weeks
measure: Medium term Prognosis
timeFrame: During the stay in neonatal unit, up to 10 weeks
measure: Prognosis evaluation
timeFrame: At the babies 1st and 2nd birthdays
Other outcomes:
Locations:
city: Brest
country: France
facility: Brest University Hospital
state: Brittany
city: Angers
country: France
facility: Angers University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Poitiers
country: France
facility: Poitiers University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Tours
country: France
facility: Tours University Hospital
Study officials:
affiliation: CHU Rennes
name: Patrick PLADYS, MD, PhD
role: STUDY_DIRECTOR
References: