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

Completed

• Conditions: Neonatal Disorder
• Interventions: Other: Data collection

• Registration Number: NCT03270410
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study Start: 2015-09-17
• Primary Completion: 2016-10-26
• Study Completion: 2016-10-26
• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-08-31
• Study First Posted: 2017-09-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-01
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neonates	Data collection	Babies born in Rennes University Hospital

Primary Outcome Measures

Name	Time	Method
Evolution of the cardiac variability during the stay in the ward	Up to 2 months	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.

Secondary Outcome Measures

Name	Time	Method
Evolution of the babies' movements during the stay in the ward	Up to 2 months	Continuous video acquisitions of the newborns are realized. Video images will be analyzed by specific routines to extract quantitative parameters of movements.
Evolution of the respiratory variability during the stay in the ward	Up to 2 months	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.

Trial Locations

Locations (1)

Rennes University Hospital; 🇫🇷 Rennes, France