Prevalence of Endolymphatic Hydrops With a Hitory of Congenital Cytomegalovirus Infection

NCT ID: NCT05229744

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-15

Study Completion Date

2025-04-22

Brief Summary

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

Detailed Description

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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.

Conditions

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Endolymphatic Hydrops

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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sequence MRI 3D FLAIR

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

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Fondation Adolphe de Rothschild

Paris, PARIS, France

Site Status

Hôpital Robert Debre

Paris, , France

Site Status

Countries

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France

Other Identifiers

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GPN_2021_23

Identifier Type: -

Identifier Source: org_study_id

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