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

Not Applicable

Completed

• Conditions: Congenital Cytomegalovirus Infection
• Interventions: Other: CMV PCR

• Registration Number: NCT02139423
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2014-04-28
• Study First Submitted QC: 2014-05-12
• Study First Posted: 2014-05-15
• Study Start: 2014-11-22
• Primary Completion: 2018-03-31
• Study Completion: 2020-10-19
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All newborns who fail universal newborn	CMV PCR	CMV PCR

Primary Outcome Measures

Name	Time	Method
Number of days necessary to obtain the result of cCMV infection diagnosis and the audiological result after formal assessment	1 month

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Necker-Enfants-Malades; 🇫🇷 Paris, France