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

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

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Disorder
• Intervention / Treatment: Other: Data collection

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.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35000
    • Rennes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study is aimed at newborns hospitalized at the CHU in Rennes

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Neonates; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Study Director: Patrick PLADYS, MD, PhD, Chu Rennes

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2015
• Primary Completion (Actual): October 26, 2016
• Study Completion (Actual): October 26, 2016

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: October 1, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: neonates; non invasive monitoring
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases
• Other Study ID Numbers: 35RC15_3012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No