Cytomegalovirus (CMV) Perilymphatic Fluid

Hearing Loss, Cochlear Clinical Trial

— CMVP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04724265
• Other study ID #: APHP191072
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2020
• Est. completion date: December 10, 2022

Study information

• Verified date: April 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Natacha TEISSIER, MD PhD
• Phone: +331.40.03.53.67
• Email: natacha.teissier[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 10, 2022
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Cytomegalovirus Congenital
• Deafness
• Hearing Loss
• Hearing Loss, Cochlear
• Hearing Loss, Sensorineural

Intervention

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.

Locations

Country	Name	City	State
France	Robert Debré Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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