RecruitingNCT07635368

Protein Biomarkers and Host RNA Expression Profiles in Congenital Cytomegalovirus Infection

Sponsor

Rigshospitalet, Denmark

Enrollment

630 participants

Start Date

Apr 21, 2026

Study Type

OBSERVATIONAL

Conditions

Sensorineural Hearing Loss Viral Infection Cytomegalovirus Infections Neonatal Infection Congenital Cytomegalovirus

Summary

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.

Eligibility

Min Age: 0 DaysMax Age: 28 Days

Inclusion Criteria3

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.

Exclusion Criteria3

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.

Interested in this trial?

Get notified about updates and connect with the research team.