Prevalence of Endolymphatic Hydrops in Patients With a History of Congenital Cytomegalovirus Infection With Symptomatic Cochleo-vestibular Involvement
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- the prevalence of at least one endolymphatic hydrops in patients with a history of congenital CMV infection with symptomatic cochleovestibular dysfunction
研究概览
简要总结
The management of patients with a history of congenital CMV infection (whether symptomatic or asymptomatic at birth) is modeled on their usual management.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
the prevalence of at least one endolymphatic hydrops in patients with a history of congenital CMV infection with symptomatic cochleovestibular dysfunction
时间窗: 4 hours after the initial injection of gadolinium, at least for one of the two ears
Endolymphatic hydrops visualized with 3D FLAIR sequence in MRI
次要结局
未报告次要终点