Biomarkers linked to congenital CMV using newborn blood spots

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study uses archived dried blood spot samples from a national newborn screening program to compare infants with confirmed congenital CMV to matched controls. The aim is to identify host protein biomarkers and RNA expression patterns that correlate with CMV-related outcomes. Analyses will focus on profiling molecular signatures that may reflect disease pathogenesis and potential future diagnostic use. The study leverages a nationwide dataset and involves retrospective case-control design to explore biomarkers and their relation to subsequent sequelae.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Paediatrics and Adolescent Medicine, Rigshospitalet
  Copenhagen, Denmark Recruiting
• Department of Congenital Disorders, Statens Serum Institut
  Copenhagen, Denmark Recruiting

Study contacts

• Principal investigator: Kia Hee Schultz Dungu, MD — Copenhagen University Hospital, Rigshospitalet
• Study coordinator: Kia Hee Schultz Dungu, MD
• Email: kia.hee.schultz.dungu@regionh.dk
• Phone: +45 22645782

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.