Prevalence of Endolymphatic Hydrops With a Hitory of Congenital Cytomegalovirus Infection

Endolymphatic Hydrops Clinical Trial

— HYDROPS-CMV  

Official title:

Prevalence of Endolymphatic Hydrops in Patients With a History of Congenital Cytomegalovirus Infection With Symptomatic Cochleo-vestibular Involvement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05229744
• Other study ID #: GPN_2021_23
• Status: Recruiting
• Start date: December 15, 2022
• Est. completion date: September 15, 2025

Study information

• Verified date: July 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: amélie YAVCHITZ
• Phone: 0148036454
• Email: ayavchitz[@]for.paris
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 15, 2025
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

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)

Related Conditions & MeSH terms

• Cytomegalovirus Infections
• Edema
• Endolymphatic Hydrops

Intervention

Device:
• 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

Locations

Country	Name	City	State
France	Hôpital Fondation Adolphe de Rothschild	Paris
France	Hôpital Robert Debre	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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