Cytomegalovirus (CMV) Perilymphatic Fluid

Not Applicable

• Conditions: Hearing Loss, Cochlear; Cytomegalovirus Congenital
• Interventions: Biological: collection of sample of perilymphatic fluid during cochlear implantation

• Registration Number: NCT04724265
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

In France, children cochlear implantation (CI) is performed 400 times per year. Causes of profound sensorineural hearing loss (SNHL) are represented by congenital malformation of the inner ear for 50 to 60%. Most of the remaining cases of CI in children are caused by congenital CMV infection. The proportion of CMV inducing SNHL with a CI in children is not clearly defined. During CI, we aim to collect a very small sample of perilymphatic fluid and to analyse it with a CMV polymerised-chain-reaction to evaluate the involvement of CMV in SNHL.

Detailed Description

Data on etiology of hearing loss and CMV status are collected. Perilymphatic liquid is collected after cochleostomy using a 1ml seringue. The drop of liquid is deposited on a Guthrie card; on another card, a drop of blood is deposited on another card. CMV PCR (polymerised chain reaction) is then performed in order to assess for the presence of CMV. The sensibility, specificity, positive and negative positive values are then calculated.

Study Timeline

• Study Start: 2020-12-10
• Study First Submitted: 2021-01-24
• Study First Submitted QC: 2021-01-24
• Study First Posted: 2021-01-26
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-15
• Last Update Posted: 2022-04-18
• Primary Completion: 2022-12-10
• Study Completion: 2022-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Children (under 18-year-old) presenting with a Sensorineural Hearing Loss with an indication of cochlear implantation

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
collection of sample of perilymphatic fluid during cochlear implantation	collection of sample of perilymphatic fluid during cochlear implantation	collection of sample of perilymphatic fluid during cochlear implantation

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of CMV PCR in perilymphatic fluid	7 days after the collection of the sample (biological collection)	CMV PCR in perilymphatic fluid

Trial Locations

Locations (1)

Robert Debré Hospital; 🇫🇷 Paris, France