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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
746
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.
Brest University Hospital
Brest, Brittany Region, France
Angers University Hospital
Angers, France
Nantes University Hospital
Nantes, France
Poitiers University Hospital
Poitiers, France
Rennes University Hospital
Rennes, France
Tours University Hospital
Tours, France
Number of newborns in neonatology unit
Time frame: Four years
Infection/Sepsis
Identification of late onset sepsis of premature newborns, materno-fœtal sepsis, and newborn infection by chorioamnionitis
Time frame: During the stay in neonatal unit, up to 10 weeks
Maturation
Quantification of maturation, i.e. evaluation of cardio respiratory rates and neurobehavioral maturation
Time frame: During the stay in neonatal unit, up to 10 weeks
Influence of environment and developmental care
Measure of impact of access to new variables (maturation, rates) on care organisation and system's perception by families (Likert scales)
Time frame: During the stay in neonatal unit, up to 10 weeks
Care givers satisfaction
Evaluation of carers' satisfaction with the new variables and the system's relevance in relation to their needs ("use cases" methods)
Time frame: Each 6 months after setting up the acquisition system in the unit
Impact on newborn's time of quiet sleep
Quantification of the relative time of quiet sleep
Time frame: At the end of the stay in neonatal unit, up to 10 weeks
Glycemia
Measures of physiological impact of hypo and hyperglycemias to assess the predictive value of hyperglycemia on sepsis risk
Time frame: During the stay in neonatal unit, up to 10 weeks
Cerebral Electrophysiology
Compared evaluation of data coming from Digi-NewB cohort with available data from EEG and polysomnography (impact of cerebral damages, broncho-pulmonary dysplasia)
Time frame: During the stay in neonatal unit, up to 10 weeks
Medium term Prognosis
Acquisition of magnetic resonance images (T1, T2, diffusion and cerebral perfusion arterial spin labeling) in neonatology
Time frame: During the stay in neonatal unit, up to 10 weeks
Prognosis evaluation
Assessment of the baby's neuro-development by Ages \& Stages Questionnaires® (ASQ) and health related events (hospitalisation, growth...)
Time frame: At the babies 1st and 2nd birthdays
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