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

Design of a Non-invasive Multi-modal Neonatal Monitoring System: Preliminary Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03270410
Acronym
VARI-NEONAT
Enrollment
35
Registered
2017-09-01
Start date
2015-09-17
Completion date
2016-10-26
Last updated
2018-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Disorder

Keywords

neonates, non invasive monitoring

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.

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.

Interventions

OTHERData 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.

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Weeks
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Evolution of the cardiac variability during the stay in the wardUp to 2 monthsThe 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

MeasureTime frameDescription
Evolution of the respiratory variability during the stay in the wardUp to 2 monthsThe 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 wardUp to 2 monthsContinuous video acquisitions of the newborns are realized. Video images will be analyzed by specific routines to extract quantitative parameters of movements.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026