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

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ClinicalTrials.gov Identifier: NCT02139423
Recruitment Status : Active, not recruiting
First Posted : May 15, 2014
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.

Condition or disease Intervention/treatment Phase
Congenital Cytomegalovirus Infection Other: CMV PCR Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 235 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : November 22, 2014
Actual Primary Completion Date : March 31, 2018
Estimated Study Completion Date : June 30, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: All newborns who fail universal newborn
CMV PCR
 Other: CMV PCR
Other Name: CMV PCR results are communicated to the relevant clinicians in real time.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Measurement of CMV by quantitative PCR [ Time Frame: 4 months ]
    correlation between the results obtained from saliva and from blood (isolated from Guthrie cards)

  2. Number of children for whom the result of the formal audiological assessment has been obtained [ Time Frame: 4 months ]
  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   up to 10 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139423


Locations
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France
Necker-Enfants-Malades
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Marianne Leruez-Ville, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02139423    
Other Study ID Numbers: CRC12025
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Congenital cytomegalovirus infection
newborn universal hearing screening
Additional relevant MeSH terms:
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Infection
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases