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Cytomegalovirus (CMV) Perilymphatic Fluid (CMVP)

Primary Purpose

Hearing Loss, Cochlear, Cytomegalovirus Congenital

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
collection of sample of perilymphatic fluid during cochlear implantation
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hearing Loss, Cochlear

Eligibility Criteria

1 Day - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • Robert Debré HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

collection of sample of perilymphatic fluid during cochlear implantation

Arm Description

collection of sample of perilymphatic fluid during cochlear implantation

Outcomes

Primary Outcome Measures

Sensitivity and specificity of CMV PCR in perilymphatic fluid
CMV PCR in perilymphatic fluid

Secondary Outcome Measures

Full Information

First Posted
January 24, 2021
Last Updated
April 15, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04724265
Brief Title
Cytomegalovirus (CMV) Perilymphatic Fluid
Acronym
CMVP
Official Title
Cytomegalovirus in Perilymphatic Fluid During Cochlear Implantation of Children Presenting a Sensorineural Hearing Loss
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
December 10, 2022 (Anticipated)
Study Completion Date
December 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Cochlear, Cytomegalovirus Congenital

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
collection of sample of perilymphatic fluid during cochlear implantation
Arm Type
Experimental
Arm Description
collection of sample of perilymphatic fluid during cochlear implantation
Intervention Type
Biological
Intervention Name(s)
collection of sample of perilymphatic fluid during cochlear implantation
Other Intervention Name(s)
collection of perilymphatic fluid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity and specificity of CMV PCR in perilymphatic fluid
Description
CMV PCR in perilymphatic fluid
Time Frame
7 days after the collection of the sample (biological collection)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children (under 18-year-old) presenting with a Sensorineural Hearing Loss with an indication of cochlear implantation Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natacha TEISSIER, MD PhD
Phone
+331.40.03.53.67
Email
natacha.teissier@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Emilien CHEBIB, MD
Phone
+336.68.66.46.87
Email
emilienchebib@gmail.com
Facility Information:
Facility Name
Robert Debré Hospital
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natacha TEISSIER, MD-PhD
Phone
+33140035367
Email
natacha.teissier@aphp.fr
First Name & Middle Initial & Last Name & Degree
Thierry VAN DEN ABBEELE, MD-PhD
Phone
+33140032449
Email
thierry.van-den-abbeele@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36369401
Citation
Chebib E, Vauloup-Fellous C, Benoit C, Noel Petroff N, Van Den Abbeele T, Maudoux A, Teissier N. Is CMV PCR of inner ear fluid during cochlear implantation a way to diagnose CMV-related hearing loss? Eur J Pediatr. 2023 Jan;182(1):375-383. doi: 10.1007/s00431-022-04691-6. Epub 2022 Nov 12.
Results Reference
derived

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Cytomegalovirus (CMV) Perilymphatic Fluid

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