Infant, Premature
Conditions
Keywords
Sepsis, Neonates, Cardio-respiratory maturation, Neurobehavioral maturation
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
Interventions
OTHERMultimodal 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.
Sponsors
Rennes University Hospital
European Union
GCS Hôpitaux Universitaires Grand-Ouest
University of Rennes
Tampere University of Technology
Voxygen Health
INESC TEC Porto
National University of Ireland, Galway, Ireland
Synchrophi Systems Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of newborns in neonatology unit | Four years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Maturation | During the stay in neonatal unit, up to 10 weeks | Quantification of maturation, i.e. evaluation of cardio respiratory rates and neurobehavioral maturation |
| 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) |
| 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) |
| 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 |
| 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 |
| 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) |
| 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 |
| 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...) |
Countries
France
Contacts
STUDY_DIRECTORPatrick PLADYS, MD, PhD
Rennes University Hospital
Outcome results
None listed