Status:

COMPLETED

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

Lead Sponsor:

Rennes University Hospital

Conditions:

Neonatal Disorder

Eligibility:

All Genders

Up to 6 years

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 s...

Eligibility Criteria

Inclusion

  • 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

  • Congenital malformation;
  • Metabolic disease.

Key Trial Info

Start Date :

September 17 2015

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

October 26 2016

Estimated Enrollment :

35 Patients enrolled

Trial Details

Trial ID

NCT03270410

Start Date

September 17 2015

End Date

October 26 2016

Last Update

October 2 2018

Active Locations (1)

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Rennes University Hospital

Rennes, France, 35000