Design of a Non-invasive Multi-modal Neonatal Monitoring System

NCT ID: NCT03270410

Last Updated: 2018-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-17

Study Completion Date

2016-10-26

Brief Summary

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This is a preliminary study whose objectives are to define the clinical use cases and the constraints of the implementation of a multi-sensor image-sound system.

Detailed Description

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300 000 newborns per year are hospitalized in European neonatal units in the post-natal period. This is a critical period for neurobehavioral development and the establishment of an optimal model of sleep-wake cycle is fundamental for brain development.

The objective of the research is to develop new tools for computer-aided clinical and predictive diagnosis and real-time monitoring in neonatology.

The development of non-invasive sensors based on video and sound images aims to improve the short- and medium-term prognosis in perinatal patients.

To that aim, multi-modal composite indices integrating the image (which is used only to generate a quantification of the movement) and the sound to the bioelectric signals already available (electrocardiogram, oxymetry, temperature) will be developed to provide diagnostic and prognostic information.

Conditions

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Neonatal Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neonates

Babies born in Rennes University Hospital

Data collection

Intervention Type OTHER

After parental information and collection of their non-opposition, the data of the daily cardio-respiratory recordings of the newborns hospitalized in the units of Neonatology are collected and analyzed.

At the same time, a video recording is set up. This video recording does not modify the care provided for the child, the organization of the day with nursing and parental care.

Interventions

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Data collection

After parental information and collection of their non-opposition, the data of the daily cardio-respiratory recordings of the newborns hospitalized in the units of Neonatology are collected and analyzed.

At the same time, a video recording is set up. This video recording does not modify the care provided for the child, the organization of the day with nursing and parental care.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* newborns less than 6 weeks old in corrected terms;
* newborns in one of the following situations:

* persistent discomfort (apneas);
* infection or suspicion of infection;
* premature with uncomplicated evolution;
* Premature brain lesion acquired in perinatal;
* newborn having been exposed to premature rupture of the membranes.

Exclusion Criteria

* Congenital malformation;
* Metabolic disease.
Maximum Eligible Age

6 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick PLADYS, MD, PhD

Role: STUDY_DIRECTOR

CHU Rennes

Locations

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Rennes University Hospital

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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35RC15_3012

Identifier Type: -

Identifier Source: org_study_id

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