Protein Biomarkers and Host RNA Expression Profiles in Congenital Cytomegalovirus Infection

Recruiting now

Conditions studied: Congenital Cytomegalovirus, Cytomegalovirus Infections, Neonatal Infection, Sensorineural Hearing Loss, Viral Infection

In brief

This study seeks to identify and test host protein biomarkers and RNA expression profiles in dried blood spot samples as novel diagnostic markers of congenital cytomegalovirus sequelae and to improve the understanding of the pathogenesis of the disease.

Key facts

Study ID

NCT07635368

Run by

Rigshospitalet, Denmark

People needed

630

Starts

2026-04-21

Expected to finish

2026-12-31

Last updated by the study team

2026-06-09

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• 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.
• 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.

You may not qualify if…

• DBS samples not approved for research use.
• DBS samples with insufficient blood material for RNA expression profiling and/or proteomic analyses.
• Samples with inadequate analytical quality for molecular or proteomic analyses.

Where it is running

• Department of Paediatrics and Adolescent Medicine, Rigshospitalet — Copenhagen, Denmark (enrolling)
• Department of Congenital Disorders, Statens Serum Institut — Copenhagen, Denmark (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.