TerminatedNot Applicable

Prevalence of Endolymphatic Hydrops With a Hitory of Congenital Cytomegalovirus Infection

Stopped: The study was discontinued due to lack of inclusion.

France18 participantsStarted 2022-12-15

Plain-language summary

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

Who can participate

Age range

6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT05229744

SponsorFondation Ophtalmologique Adolphe de Rothschild

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2025-04-22

View on ClinicalTrials.gov More Endolymphatic Hydrops trials

Who can participate

Age range

6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.