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Trial record 3 of 16 for:    VARI

Design of a Non-invasive Multi-modal Neonatal Monitoring System (VARI-NEONAT)

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ClinicalTrials.gov Identifier: NCT03270410
Recruitment Status : Completed
First Posted : September 1, 2017
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Neonatal Disorder Other: Data collection

Detailed Description:

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.


Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Design of a Non-invasive Multi-modal Neonatal Monitoring System: Preliminary Observational Study
Actual Study Start Date : September 17, 2015
Actual Primary Completion Date : October 26, 2016
Actual Study Completion Date : October 26, 2016

Group/Cohort Intervention/treatment
Neonates
Babies born in Rennes University Hospital
Other: 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.





Primary Outcome Measures :
  1. Evolution of the cardiac variability during the stay in the ward [ Time Frame: Up to 2 months ]
    The cardiac signals collected by the clinical monitoring required for hospitalization in a neonatal unit will be analyzed by specific routines to calculate parameters of cardiac variability.


Secondary Outcome Measures :
  1. Evolution of the respiratory variability during the stay in the ward [ Time Frame: Up to 2 months ]
    The respiratory signals collected by the clinical monitoring required for hospitalization in a neonatal unit will be analyzed by specific routines to calculate parameters of respiratory variability.

  2. Evolution of the babies' movements during the stay in the ward [ Time Frame: Up to 2 months ]
    Continuous video acquisitions of the newborns are realized. Video images will be analyzed by specific routines to extract quantitative parameters of movements.



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Ages Eligible for Study:   up to 6 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study is aimed at newborns hospitalized at the CHU in Rennes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270410


Locations
France
Rennes University Hospital
Rennes, France, 35000
Sponsors and Collaborators
Rennes University Hospital
Investigators
Study Director: Patrick PLADYS, MD, PhD CHU Rennes

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03270410     History of Changes
Other Study ID Numbers: 35RC15_3012
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rennes University Hospital:
neonates
non invasive monitoring

Additional relevant MeSH terms:
Infant, Newborn, Diseases