Diagnosis of Congenital CMV Infection in Neonates Who Failed Newborn Hearing Screening
CYMEAUDIT
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
2 other identifiers
interventional
235
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2014
Longer than P75 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
First Submitted
Initial submission to the registry
April 28, 2014
CompletedFirst Posted
Study publicly available on registry
May 15, 2014
CompletedStudy Start
First participant enrolled
November 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 19, 2020
CompletedMarch 27, 2026
March 1, 2026
3.4 years
April 28, 2014
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of days necessary to obtain the result of cCMV infection diagnosis and the audiological result after formal assessment
1 month
Secondary Outcomes (3)
Measurement of CMV by quantitative PCR
4 months
Number of children for whom the result of the formal audiological assessment has been obtained
4 months
Number of children with cCMV infection and confirmed hearing loss in whom antiviral therapy has been initiated within the first month of life
4 months
Study Arms (1)
All newborns who fail universal newborn
EXPERIMENTALCMV PCR
Interventions
Eligibility Criteria
You may qualify if:
- All newborns who have failed universal newborn screening
You may not qualify if:
- Neonates whose mothers would object to the use of their child's medical data
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Necker-Enfants-Malades
Paris, 75015, France
Related Publications (1)
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.
PMID: 35093998RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marianne Leruez-Ville, MD, PhD
Assistance Publique - Hôpitaux de Paris
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
April 28, 2014
First Posted
May 15, 2014
Study Start
November 22, 2014
Primary Completion
March 31, 2018
Study Completion
October 19, 2020
Last Updated
March 27, 2026
Record last verified: 2026-03