NCT04724265

Cytomegalovirus (CMV) Perilymphatic Fluid

Cytomegalovirus in Perilymphatic Fluid During Cochlear Implantation of Children Presenting a Sensorineural Hearing Loss

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 1 Day – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hearing Loss, Cochlear
• Cytomegalovirus Congenital

Interventions

Type	Name	Description
BIOLOGICAL	collection of sample of perilymphatic fluid during cochlear implantation	collection of sample of perilymphatic fluid during cochlear implantation and to analyse it with a CMV polymerised-chain-reaction to evaluate the involvement of CMV in hearing loss.

Timeline

• Start date: 2020-12-10
• Primary completion: 2022-12-10
• Completion: 2022-12-10
• First posted: 2021-01-26
• Last updated: 2022-04-18

Locations

1 site across 1 country: France