Clinical trial NCT05229744: Prevalence of Endolymphatic Hydrops With a Hitory of Congenital Cytomegalovirus Infection
Official title: Prevalence of Endolymphatic Hydrops in Patients With a History of Congenital Cytomegalovirus Infection With Symptomatic Cochleo-vestibular Involvement
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endolymphatic Hydrops
Keywords: CMV
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2022-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

Eligibility criteria: 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)

Primary outcomes:
measure: the prevalence of at least one endolymphatic hydrops in patients with a history of congenital CMV infection with symptomatic cochleovestibular dysfunction
timeFrame: 4 hours after the initial injection of gadolinium, at least for one of the two ears
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation Adolphe de Rothschild
city: Paris
country: France
facility: Hôpital Robert Debre
Study officials:
References: