Status:

COMPLETED

Brainstem Dysfunction Involvement in the Pathogenesis of Pierre Robin Sequence

Lead Sponsor:

Hospices Civils de Lyon

Conditions:

Pierre Robin Sequence

Brainstem Dysfunction

Eligibility:

All Genders

1-2 years

Phase:

NA

Brief Summary

Introduction Pierre Robin Sequence, PRS, incidence is about one hundred births per year in France. The main neonatal clinical manifestations are secondary to airway obstruction and food difficulties r...

Eligibility Criteria

Inclusion

  • Inclusion Criteria for the group 1
  • \- infants with PRS
  • Inclusion Criteria for the group 2 - infant with isolated airway obstruction
  • Inclusion Criteria for the group 3
  • \- healthy infant : siblings of sudden unexpected death of the infant or with any known pathology
  • Inclusion Criteria for the 3 groups
  • During one hospitalization or program for one hospitalization
  • Parental consent
  • Social safety affiliation
  • Exclusion Criteria:
  • Birth before 37 SA
  • Neonatal complication
  • Group 2 only: AWO with neurological disease including brainstem dysfunction
  • Group 3 only : AWO, ENT disease or syndromic disease, neurological disease including brainstem dysfunction, Intra uterine growth retardation

Exclusion

    Key Trial Info

    Start Date :

    May 24 2018

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 23 2023

    Estimated Enrollment :

    113 Patients enrolled

    Trial Details

    Trial ID

    NCT03423017

    Start Date

    May 24 2018

    End Date

    March 23 2023

    Last Update

    January 10 2024

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Hopital Femme Mère Enfant

    Bron, France, 69500

    2

    APHP-Necker

    Paris, France, 75015 Paris