Targeted congenital CMV screening guided by newborn hearing screening
Official title: Overview of Targeted Screening for Congenital Infection Guided by Neonatal Hearing Screening
Run by University Hospital, Strasbourg, France · NCT07335874 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 0 Years to 1 Month |
| Sex | All |
| Enrollment | 450 (estimated) |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Status | Recruiting |
| Started | June 16, 2025 |
| Main results expected | June 2026 |
| Study ends | June 16, 2026 |
| Registry record updated | January 13, 2026 |
| Trial ID | NCT07335874 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.