Diagnosis of Congenital CMV Infection in Neonates Who Fai... | NCT02139423

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

NCT02139423

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Mar 27, 2026Actual

Enrollment

235Actual

Phase

Not Applicable

Conditions

Congenital Cytomegalovirus Infection

Interventions

CMV PCR

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CRC12025	Other Identifier	CRC

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 22, 2014Actual

Primary Completion Date

Mar 31, 2018Actual

Completion Date

Oct 19, 2020Actual

First Submitted Date

Apr 28, 2014

First Submission Date that Met QC Criteria

May 12, 2014

First Posted Date

May 15, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2026

Last Update Posted Date

Mar 27, 2026Actual

Name	Class
URC-CIC Paris Descartes Necker Cochin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

235Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All newborns who fail universal newborn	Experimental	CMV PCR	Other: CMV PCR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CMV PCR	Other		All newborns who fail universal newborn	CMV PCR results are communicated to the relevant clinicians in real time.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of days necessary to obtain the result of cCMV infection diagnosis and the audiological result after formal assessment		1 month

Secondary Outcomes

Measure	Description	Time Frame
Measurement of CMV by quantitative PCR	correlation between the results obtained from saliva and from blood (isolated from Guthrie cards)	4 months
Number of children for whom the result of the formal audiological assessment has been obtained

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

10 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marianne Leruez-Ville, MD, PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Necker-Enfants-Malades		Paris		75015	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35093998	Result	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.

ID	Term
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections