NCT03270410

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
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 6 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Neonatal Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-09-17
• Primary completion: 2016-10-26
• Completion: 2016-10-26
• First posted: 2017-09-01
• Last updated: 2018-10-02

Locations

1 site across 1 country: France