Cytomegalovirus (CMV) Perilymphatic Fluid

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04724265

Acronym

CMVP

Enrollment

200

Registered

2021-01-26

Start date

2020-12-10

Completion date

2022-12-10

Last updated

2022-04-18

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

Conditions

Cytomegalovirus Congenital, Hearing Loss, Cochlear

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.

Interventions

BIOLOGICALcollection 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Days to 18 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity and specificity of CMV PCR in perilymphatic fluid	7 days after the collection of the sample (biological collection)	CMV PCR in perilymphatic fluid

Countries

France

Contacts

Primary ContactNatacha TEISSIER, MD PhD

natacha.teissier@aphp.fr+331.40.03.53.67

Backup ContactEmilien CHEBIB, MD

emilienchebib@gmail.com+336.68.66.46.87

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026