Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Newborn blood spots may reveal hidden risks from common virus

NCT ID NCT07635368

Knowledge-focused Sponsor: Rigshospitalet, Denmark Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study analyzes dried blood spots from 630 newborns to find protein and RNA markers that could predict which babies with congenital CMV will develop hearing loss or other problems. Researchers will compare samples from infected babies who had complications, those who did not, and healthy controls. The goal is to improve understanding of the disease and potentially develop a screening test.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple blood test at birth to identify which babies with congenital CMV are at risk for hearing loss or other problems.
What could go wrong
This is an observational study, not a treatment trial. It may not find reliable markers, and any future test would need years of additional validation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 630 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population consists of children born in Denmark between January 1, 2010 and December 31, 2025 with available neonatal dried blood spot samples collected through the Danish National Newborn Screening Program. The study includes children with verified congenital cytomegalovirus (CMV) infection and matched controls without congenital CMV infection. Children with congenital CMV infection will be categorized according to the presence or absence of CMV-associated sequelae based on clinical follow-up data.

Ages

0 to 28 days

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Children born between 1 January 2010 and 31 December 2025 with an available neonatal dried blood spot sample collected through the Danish National Newborn Screening Program. 2. Cases: children with verified congenital CMV infection, defined as a positive CMV PCR result on neonatal dried blood spot, blood, or urine collected within the neonatal period. 3. Controls: children without evidence of congenital CMV infection selected from the same newborn screening population and matched to cases on sex, gestational age, birthweight, and age at DBS sampling. Exclusion Criteria: 1. DBS samples not approved for research use. 2. DBS samples with insufficient blood material for RNA expression profiling and/or proteomic analyses. 3. Samples with inadequate analytical quality for molecular or proteomic analyses.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Congenital cytomegalovirus are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

cytomegalovirus infection fetal cytomegalovirus syndrome Hearing Loss, Sensorineural sensorineural hearing loss disorder viral infectious disease X-linked mixed hearing loss with perilymphatic gusher

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congenital cytomegalovirus Cytomegalovirus infections Neonatal infection Sensorineural hearing loss Viral infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Congenital Disorders, Statens Serum Institut

    RECRUITING

    Copenhagen, 2300, Denmark

  • Department of Paediatrics and Adolescent Medicine, Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.