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

Neonatal Disorder Clinical Trial

— VARI-NEONAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03270410
• Other study ID #: 35RC15_3012
• Status: Completed
• Start date: September 17, 2015
• Est. completion date: October 26, 2016

Study information

• Verified date: October 2018
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 26, 2016
• Est. primary completion date: October 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Infant, Newborn, Diseases
• Neonatal Disorder

Intervention

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.

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of the cardiac variability during the stay in the ward	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.	Up to 2 months
Secondary	Evolution of the respiratory variability during the stay in the ward	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.	Up to 2 months
Secondary	Evolution of the babies' movements during the stay in the ward	Continuous video acquisitions of the newborns are realized. Video images will be analyzed by specific routines to extract quantitative parameters of movements.	Up to 2 months