Plain-English translation of NCT07635368 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This study is looking for new biological markers — essentially fingerprints in the blood — that could help doctors predict which babies born with congenital CMV (a common viral infection passed from mother to baby before birth) will develop hearing loss or other problems. Researchers will compare blood samples collected at birth from babies with CMV infection to samples from babies without the infection, using advanced laboratory techniques to identify patterns that might warn of future complications.
Right now, doctors have no reliable way to predict which babies with congenital CMV will develop serious complications like hearing loss later in childhood. This means many affected children miss the window for early treatment that could help prevent permanent disability. This study aims to create a new diagnostic tool that could identify at-risk babies early, so they can receive timely care.
You likely qualify if…
You likely don't qualify if…
Participation is entirely retrospective — researchers will access dried blood spots already collected as part of routine newborn screening in Denmark. No new visits or procedures are needed from participants. The research team will analyze these existing samples using specialized laboratory techniques to identify blood markers associated with CMV infection and the development of hearing loss, comparing samples from affected babies to healthy control babies matched by age and birth characteristics.
AI-generated summary from trial data · Aug 29, 2026 · Not medical advice
Denmark
Sponsor
Copenhagen University Hospital, Rigshospitalet
Collaborators
Statens Serum Institut
Enrollment target
~630 participants
Started
April 2026
Primary completion
September 2026
This trial's estimated completion date has passed — the record may not be fully up to date.
Age range
0 Days – 28 Days
Last updated on clinicaltrials.gov in June 2026.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Kia Hee Schultz Dungu, MD
Copenhagen University Hospital, Rigshospitalet
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.