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CompletedNCT03270410VARI-NEONATUpdated Oct 2, 2018

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

An observational study in Neonatal Disorder, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to participants aged Up to 6 Weeks. Per ClinicalTrials.gov, last updated 2018-10-02.

Sponsored by Rennes University Hospital · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
35
Ages
Up to 6 Weeks
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Neonatal Disorder

Keywords

  • neonates
  • non invasive monitoring
03

In context

Infant, Newborn, Diseases

140 studies on the registry are indexed under Infant, Newborn, Diseases; 29 are open to participants now.

This study's enrollment of 35 is below the median of 100 across 49 observational studies indexed under Infant, Newborn, Diseases.

Browse Infant, Newborn, Diseases studies →

Lead sponsor

Rennes University Hospital is the lead sponsor of 451 studies on the registry; 51 are open to participants now.

Browse Rennes University Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 6 Weeks
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Congenital malformation;
  • Metabolic disease.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
35 participants (actual)
Patient registry
No

Groups and cohorts

  • Neonates

    Babies born in Rennes University Hospital

    Other: Data collection

Interventions

  • OtherData 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 2 months

Secondary outcomes

  1. 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.

    Time frame: Up to 2 months

  2. 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.

    Time frame: Up to 2 months

07

Study locations

1 site
  • Rennes University Hospital
    Rennes, 35000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2015 to primary completion in Oct 2016, 13 months.

Of 32 observational studies under Infant, Newborn, Diseases, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 39. This study's 13 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 23, 2017
First posted
Sep 1, 2017
StartActual
Sep 17, 2015
Primary completionActual
Oct 26, 2016
CompletionActual
Oct 26, 2016
Last update
Oct 2, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03270410
Lead sponsor
Rennes University Hospital
Responsible party
Sponsor
First posted
Sep 1, 2017
Start date
Sep 17, 2015
Primary completion
Oct 26, 2016
Completion
Oct 26, 2016
Last update
Oct 2, 2018

Study contacts

Patrick PLADYS, MD, PhD
study director · CHU Rennes

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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