Targeted congenital CMV screening guided by newborn hearing screening
Overview of Targeted Screening for Congenital Infection Guided by Neonatal Hearing Screening
University Hospital, Strasbourg, France · NCT07335874
This project will test whether doing a CMV test for babies under one month who have an inconclusive newborn hearing screening can find congenital CMV infections earlier.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 0 Years to 1 Month |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France (other) |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT07335874 on ClinicalTrials.gov |
What this trial studies
This observational project enrolls newborns aged 0–1 month who have an inconclusive newborn hearing screening retest (T2) between August 2024 and the end of July 2025 and performs CMV PCR testing within the first month of life. Infants with a CMV PCR performed for another reason or with PCR sampled after one month are excluded. The goal is to measure how often targeted CMV testing following an inconclusive hearing screen identifies congenital CMV and to describe implications for hearing and pediatric follow-up. Data will be collected at the University Hospital Strasbourg outpatient/service site and used to inform management pathways for affected infants.
Who should consider this trial
Good fit: Newborns 0–1 month old with an inconclusive unilateral or bilateral newborn hearing screening retest (T2) between August 2024 and July 2025 who have not had CMV PCR for another indication.
Not a fit: Infants who had CMV PCR after one month of age, those already tested for CMV for other clinical reasons, and newborns without an inconclusive hearing screen are unlikely to benefit from this targeted approach.
Why it matters
Potential benefit: If successful, this approach could identify babies with congenital CMV earlier so they receive tailored hearing, neurological, and ophthalmological monitoring.
How similar studies have performed: Similar targeted CMV screening approaches after failed or inconclusive newborn hearing screens have previously identified additional congenital CMV cases, although universal newborn CMV screening remains debated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Minors aged 0 to 1 month at the time of newborn hearing screening * Subject with inconclusive newborn hearing screening (NHS) on unilateral or bilateral T2 (inconclusive retest) between August 2024 and the end of July 2025. Exclusion Criteria: * Positive CMV PCR after 1 month of life * CMV PCR performed for another indication.
Where this trial is running
Strasbourg
- Service d'ORL et de Chirurgie Cervico-faciale - CHU de Strasbourg - France — Strasbourg, France (RECRUITING)
Study contacts
- Study coordinator: Carine EYERMANN, MD
- Email: carine.eyermann@chru-strasbourg.fr
- Phone: 33 3 88 12 76 56
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neonatal Hearing Loss, Neonatal hearing loss, Cytomegalovirus infection, Congenital infection, Sensorineural hearing loss