Prevalence of Endolymphatic Hydrops With a Hitory of Congenital Cytomegalovirus Infection

Recruiting

• Conditions: Endolymphatic Hydrops

• Registration Number: NCT05229744
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-09-29
• Study First Submitted QC: 2022-02-07
• Study First Posted: 2022-02-08
• Study Start: 2022-12-15
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27
• Primary Completion: 2024-12-15
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the prevalence of at least one endolymphatic hydrops in patients with a history of congenital CMV infection with symptomatic cochleovestibular dysfunction	4 hours after the initial injection of gadolinium, at least for one of the two ears	Endolymphatic hydrops visualized with 3D FLAIR sequence in MRI

Trial Locations

Locations (2)

Hôpital Fondation Adolphe de Rothschild; 🇫🇷 Paris, France

Hôpital Robert Debre; 🇫🇷 Paris, France