Prevalence of Endolymphatic Hydrops With a Hitory of Congenital Cytomegalovirus Infection

NCT05229744 | Terminated

• 1 other identifier: GPN_2021_23
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

Endolymphatic Hydrops

Keywords

CMV

Outcome Measures

Primary Outcomes (1)

• the prevalence of at least one endolymphatic hydrops in patients with a history of congenital CMV infection with symptomatic cochleovestibular dysfunction

  Endolymphatic hydrops visualized with 3D FLAIR sequence in MRI

  4 hours after the initial injection of gadolinium, at least for one of the two ears

Interventions

sequence MRI 3D FLAIR DEVICE

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

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a confirmed history of congenital CMV infection with symptomatic cochleo-vestibular dysfunction (mean hearing threshold\> 20dB in at least one ear and / or functional abnormality in one or more areas at the vestibular level)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (2)

Hôpital Fondation Adolphe de Rothschild

Paris, PARIS, 75019, France

Location

Hôpital Robert Debre

Paris, 75019, France

Location

MeSH Terms

Conditions

Endolymphatic Hydrops

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: February 8, 2022
• Study Start: December 15, 2022
• Primary Completion: April 22, 2025
• Study Completion: April 22, 2025
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)