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Diagnosis of Congenital CMV Infection in Neonates Who Failed Newborn Hearing Screening (CymeAudit)

Primary Purpose

Congenital Cytomegalovirus Infection

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CMV PCR
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Congenital Cytomegalovirus Infection focused on measuring Congenital cytomegalovirus infection, newborn universal hearing screening

Eligibility Criteria

1 Day - 10 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All newborns who have failed universal newborn screening

Exclusion Criteria:

  • Neonates whose mothers would object to the use of their child's medical data

Sites / Locations

  • Necker-Enfants-Malades

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All newborns who fail universal newborn

Arm Description

CMV PCR

Outcomes

Primary Outcome Measures

Number of days necessary to obtain the result of cCMV infection diagnosis and the audiological result after formal assessment

Secondary Outcome Measures

Measurement of CMV by quantitative PCR
correlation between the results obtained from saliva and from blood (isolated from Guthrie cards)
Number of children for whom the result of the formal audiological assessment has been obtained
Number of children with cCMV infection and confirmed hearing loss in whom antiviral therapy has been initiated within the first month of life

Full Information

First Posted
April 28, 2014
Last Updated
September 22, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02139423
Brief Title
Diagnosis of Congenital CMV Infection in Neonates Who Failed Newborn Hearing Screening
Acronym
CymeAudit
Official Title
Feasibility to Achieve, Before One Month of Age, the Diagnosis of Congenital CMV Diagnosis and the Formal Audiologic Assessment in Newborns Who Failed Newborn Hearing Screening
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 22, 2014 (Actual)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
October 19, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Universal hearing screening at birth by use of otoacoustic emission (OAE) is now offered in most maternities in France to detect symptomatic hearing impairment at birth but screening of cCMV infection is not coupled with this screening. In this study, the feasibility of achieving before one month of age the diagnosis of congenital CMV diagnosis and as well as the confirmation of hearing loss in newborns who failed newborn hearing screening will be tested.
Detailed Description
Congenital cytomegalovirus (cCMV) is the most frequent congenital infection in France. Around 90% of cCMV infected infants are asymptomatic at birth, of whom 7 to 20% develop sensorineural hearing loss (SNHL). cCMV explains at least 10% of all hearing loss cases in young children. Early antiviral treatment (implemented before 1 month of age) with ganciclovir or valganciclovir can improve hearing outcome. In the absence of universal screening, cCMV remains largely undetected because most infected neonates are asymptomatic or have non-specific symptoms. When symptoms become apparent or develop, it may be too late for confirmation that the infection is of congenital origin becausediagnosis of congenital infection is based on the detection of CMV in samples collected within 2 to 3 weeks after birth. The presence of CMV in samples collected after this time may represent postnatal infection which does not carry the risk of hearing loss or neurodevelopmental sequelae. Universal hearing screening at birth by use of otoacoustic emission (OAE) is now offered in most maternities in France to detect symptomatic hearing impairment at birth but screening of cCMV infection is not coupled with this screening. In this study, the feasibility of achieving before one month of age the diagnosis of congenital CMV diagnosis and as well as the confirmation of hearing loss in newborns who failed newborn hearing screening will be tested.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Cytomegalovirus Infection
Keywords
Congenital cytomegalovirus infection, newborn universal hearing screening

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
All newborns who fail universal newborn
Arm Type
Experimental
Arm Description
CMV PCR
Intervention Type
Other
Intervention Name(s)
CMV PCR
Other Intervention Name(s)
CMV PCR results are communicated to the relevant clinicians in real time.
Primary Outcome Measure Information:
Title
Number of days necessary to obtain the result of cCMV infection diagnosis and the audiological result after formal assessment
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Measurement of CMV by quantitative PCR
Description
correlation between the results obtained from saliva and from blood (isolated from Guthrie cards)
Time Frame
4 months
Title
Number of children for whom the result of the formal audiological assessment has been obtained
Time Frame
4 months
Title
Number of children with cCMV infection and confirmed hearing loss in whom antiviral therapy has been initiated within the first month of life
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
10 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All newborns who have failed universal newborn screening Exclusion Criteria: Neonates whose mothers would object to the use of their child's medical data
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Leruez-Ville, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Necker-Enfants-Malades
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
35093998
Citation
Fourgeaud J, Boithias C, Walter-Nicolet E, Kermorvant E, Couderc S, Parat S, Pol C, Mousset C, Bussieres L, Guilleminot T, Ville Y, Nkam L, Grimaldi L, Parodi M, Leruez-Ville M. Performance of Targeted Congenital Cytomegalovirus Screening in Newborns Failing Universal Hearing Screening: A Multicenter Study. Pediatr Infect Dis J. 2022 Jun 1;41(6):478-481. doi: 10.1097/INF.0000000000003474. Epub 2022 Jan 27.
Results Reference
derived

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Diagnosis of Congenital CMV Infection in Neonates Who Failed Newborn Hearing Screening

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