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Completed

NCT Number: NCT03270410

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

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.

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Key information

Age range

Up to 6 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Rennes University Hospital

Rennes, 35000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Collection

Other

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.

Primary outcomes

  1. Evolution of the cardiac variability during the stay in the ward

    Time frame: 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 outcomes

  1. Evolution of the respiratory variability during the stay in the ward

    Time frame: 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.

  2. Evolution of the babies' movements during the stay in the ward

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: VARI-NEONAT

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 1, 2017
Registry last updated
Oct 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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