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Prevalence of Endolymphatic Hydrops With a Hitory of Congenital Cytomegalovirus Infection (HYDROPS-CMV)

F

Fondation Ophtalmologique Adolphe de Rothschild

Status

Terminated

Conditions

Endolymphatic Hydrops

Treatments

Device: sequence MRI 3D FLAIR

Study type

Observational

Funder types

NETWORK

Identifiers

NCT05229744
GPN_2021_23

Details and patient eligibility

About

The management of patients with a history of congenital CMV infection (whether symptomatic or asymptomatic at birth) is modeled on their usual management.

Full description

The management of patients with a history of congenital CMV infection (whether symptomatic or asymptomatic at birth) is modeled on their usual management.

Patients benefit as part of the care:

  • A clinical cochleo-vestibular examination
  • Functional otoneurological explorations: audiogram, caloric tests, vHIT, otolithic evoked potentials
  • From an uninjected brain MRI

Participation in this research entails the addition of an MRI sequence and an injection of contrast product (Gadovist®):

- 3D FLAIR MRI sequence dedicated to the exploration of the inner ear, lasting 6min30s, performed 4 hours after the initial injection of contrast product.

Enrollment

18 patients

Sex

All

Ages

6+ months old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient over 6 months old
  • With a history of confirmed congenital CMV infection
  • Suffering from symptomatic cochleo-vestibular dysfunction (average hearing threshold> 20dB in at least one ear and / or abnormal functioning of one or more sectors at the vestibular level)
  • For adult patients, having received informed information about the study and having signed a consent to participate in the study
  • For minor patients written consent of the two holders of the exercise of parental authority
  • Affiliate or beneficiary of a social security scheme

Exclusion criteria

  • Patient benefiting from a legal protection measure
  • Pregnant or breastfeeding woman
  • Contraindication to MRI (implanted electrical device, metallic foreign body, claustrophobia)
  • Patient with a proven allergy to gadolinium
  • Injection of gadolinium in the previous 7 days
  • Known impairment of renal function ((estimated GFR <60 mL / min / 1.73 m²)

Trial contacts and locations

2

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Central trial contact

amélie YAVCHITZ; guillaume POILLON

Data sourced from clinicaltrials.gov

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