Cytomegalovirus (CMV) Perilymphatic Fluid (CMVP)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Cytomegalovirus Congenital; Hearing Loss, Cochlear

Treatments: Biological: collection of sample of perilymphatic fluid during cochlear implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT04724265

APHP191072

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 1 day to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

collection of sample of perilymphatic fluid during cochlear implantation

Experimental group

Description:

collection of sample of perilymphatic fluid during cochlear implantation

Treatment:

Biological: collection of sample of perilymphatic fluid during cochlear implantation