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

Congenital Cytomegalovirus Infection Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139423
• Other study ID #: CRC12025
• Status: Completed
• Phase: N/A
• Start date: November 22, 2014
• Est. completion date: October 19, 2020

Study information

• Verified date: September 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: October 19, 2020
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Days

Eligibility

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

Related Conditions & MeSH terms

• Congenital Cytomegalovirus Infection
• Cytomegalovirus Infections
• Infections

Intervention

Other:
• CMV PCR

Locations

Country	Name	City	State
France	Necker-Enfants-Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days necessary to obtain the result of cCMV infection diagnosis and the audiological result after formal assessment		1 month
Secondary	Measurement of CMV by quantitative PCR	correlation between the results obtained from saliva and from blood (isolated from Guthrie cards)	4 months
Secondary	Number of children for whom the result of the formal audiological assessment has been obtained		4 months
Secondary	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