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Prevalence of Endolymphatic Hydrops With a Hitory of Congenital Cytomegalovirus Infection

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05229744
Acronym
HYDROPS-CMV
Enrollment
18
Registered
2022-02-08
Start date
2022-12-15
Completion date
2025-04-22
Last updated
2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endolymphatic Hydrops

Keywords

CMV

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.

Interventions

DEVICEsequence 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

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
the prevalence of at least one endolymphatic hydrops in patients with a history of congenital CMV infection with symptomatic cochleovestibular dysfunction4 hours after the initial injection of gadolinium, at least for one of the two earsEndolymphatic hydrops visualized with 3D FLAIR sequence in MRI

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026