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

Rennes University Hospital

Status

Completed

Conditions

Neonatal Disorder

Treatments

Other: Data collection

Study type

Observational

Funder types

Other

Identifiers

NCT03270410

35RC15_3012

Details and patient eligibility

About

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.

Full 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.

Enrollment

35 patients

Sex

All

Ages

Under 6 weeks old

Volunteers

No Healthy Volunteers

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.