Cytomegalovirus (CMV) Perilymphatic Fluid

NCT ID: NCT04724265

Last Updated: 2022-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-10

Study Completion Date

2022-12-10

Brief Summary

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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

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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.

Conditions

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Hearing Loss, Cochlear Cytomegalovirus Congenital

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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collection of sample of perilymphatic fluid during cochlear implantation

collection of sample of perilymphatic fluid during cochlear implantation

Group Type EXPERIMENTAL

collection of sample of perilymphatic fluid during cochlear implantation

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Other Intervention Names

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collection of perilymphatic fluid

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Robert Debré Hospital

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Natacha TEISSIER, MD PhD

Role: CONTACT

+331.40.03.53.67

Emilien CHEBIB, MD

Role: CONTACT

+336.68.66.46.87

Facility Contacts

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Natacha TEISSIER, MD-PhD

Role: primary

+33140035367

Thierry VAN DEN ABBEELE, MD-PhD

Role: backup

+33140032449

References

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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.

Reference Type DERIVED
PMID: 36369401 (View on PubMed)

Other Identifiers

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APHP191072

Identifier Type: -

Identifier Source: org_study_id

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