Cytomegalovirus (CMV) Perilymphatic Fluid
CMVP
Cytomegalovirus in Perilymphatic Fluid During Cochlear Implantation of Children Presenting a Sensorineural Hearing Loss
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 10, 2020
CompletedFirst Submitted
Initial submission to the registry
January 24, 2021
CompletedFirst Posted
Study publicly available on registry
January 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2022
CompletedApril 18, 2022
April 1, 2022
2 years
January 24, 2021
April 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity and specificity of CMV PCR in perilymphatic fluid
CMV PCR in perilymphatic fluid
7 days after the collection of the sample (biological collection)
Study Arms (1)
collection of sample of perilymphatic fluid during cochlear implantation
EXPERIMENTALcollection of sample of perilymphatic fluid during cochlear implantation
Interventions
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.
Eligibility Criteria
You may qualify if:
- Children (under 18-year-old) presenting with a Sensorineural Hearing Loss with an indication of cochlear implantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Robert Debré Hospital
Paris, 75019, France
Related Publications (1)
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.
PMID: 36369401DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2021
First Posted
January 26, 2021
Study Start
December 10, 2020
Primary Completion
December 10, 2022
Study Completion
December 10, 2022
Last Updated
April 18, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share