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
|Condition or disease||Intervention/treatment|
|Neonatal Disorder||Other: Data collection|
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|
|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|
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.
- 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.
- 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.
- 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.
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
|Rennes University Hospital|
|Rennes, France, 35000|
|Study Director:||Patrick PLADYS, MD, PhD||CHU Rennes|