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

Infant, Premature Clinical Trial

— Digi-NewB  

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Infant, Premature

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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