Diagnosis of Congenital CMV Infection in Neonates Who Failed Newborn Hearing Screening
NCT02139423 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 235
Last updated 2026-03-27
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.
Conditions
- Congenital Cytomegalovirus Infection
Interventions
- OTHER
-
CMV PCR
Sponsors & Collaborators
-
URC-CIC Paris Descartes Necker Cochin
collaborator OTHER -
Assistance Publique - Hôpitaux de Paris
lead OTHER
Principal Investigators
-
Marianne Leruez-Ville, MD, PhD · Assistance Publique - Hôpitaux de Paris
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Day
- Max Age
- 10 Days
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-11-22
- Primary Completion
- 2018-03-31
- Completion
- 2020-10-19
Countries
- France
Study Locations
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