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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02863978
Other study ID # 35RC16_9714
Secondary ID 2016-A00993-48
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 8, 2016
Est. completion date June 10, 2024

Study information

Verified date December 2022
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 746
Est. completion date June 10, 2024
Est. primary completion date June 10, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 6 Weeks
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France Angers University Hospital Angers
France Brest University Hospital Brest Brittany
France Nantes University Hospital Nantes
France Poitiers University Hospital Poitiers
France Rennes University Hospital Rennes
France Tours University Hospital Tours

Sponsors (9)

Lead Sponsor Collaborator
Rennes University Hospital European Union, GCS Hôpitaux Universitaires Grand-Ouest, INESC TEC Porto, National University of Ireland, Galway, Ireland, Rennes 1 University, Synchrophi Systems Ltd, Tampere University of Technology, Voxygen Health

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of newborns in neonatology unit Four years
Secondary Infection/Sepsis Identification of late onset sepsis of premature newborns, materno-fœtal sepsis, and newborn infection by chorioamnionitis During the stay in neonatal unit, up to 10 weeks
Secondary Maturation Quantification of maturation, i.e. evaluation of cardio respiratory rates and neurobehavioral maturation During the stay in neonatal unit, up to 10 weeks
Secondary 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) During the stay in neonatal unit, up to 10 weeks
Secondary Care givers satisfaction Evaluation of carers' satisfaction with the new variables and the system's relevance in relation to their needs ("use cases" methods) Each 6 months after setting up the acquisition system in the unit
Secondary Impact on newborn's time of quiet sleep Quantification of the relative time of quiet sleep At the end of the stay in neonatal unit, up to 10 weeks
Secondary Glycemia Measures of physiological impact of hypo and hyperglycemias to assess the predictive value of hyperglycemia on sepsis risk During the stay in neonatal unit, up to 10 weeks
Secondary 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) During the stay in neonatal unit, up to 10 weeks
Secondary Medium term Prognosis Acquisition of magnetic resonance images (T1, T2, diffusion and cerebral perfusion arterial spin labeling) in neonatology During the stay in neonatal unit, up to 10 weeks
Secondary Prognosis evaluation Assessment of the baby's neuro-development by Ages & Stages Questionnaires® (ASQ) and health related events (hospitalisation, growth...) At the babies 1st and 2nd birthdays
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