Congenital Cytomegalovirus Clinical Trials

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Protein Biomarkers and Host RNA Expression Profiles in Congenital Cytomegalovirus Infection

Status: Recruiting

Location: See all (2) locations...

Study Type: Observational

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

Participation Requirements

Sex: All

Maximum Age: 28 days

Healthy Volunteers: t

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• 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.

Locations

Other Locations

Denmark

Department of Congenital Disorders, Statens Serum Institut

RECRUITING

Copenhagen

Department of Paediatrics and Adolescent Medicine, Rigshospitalet

RECRUITING

Copenhagen

Contact Information

Primary

Kia Hee Schultz Dungu, MD

kia.hee.schultz.dungu@regionh.dk

+45 22645782

Backup

Ulrikka Nygaard, Ass Prof PhD

Ulrikka.Nygaard@regionh.dk

+45 35459761

Time Frame

Start Date: 2026-04-21

Estimated Completion Date: 2026-12-31

Participants

Target number of participants: 630

Treatments

Cases

300 children with symptomatic congenital CMV infection.~Study procedures:~Diagnostic/prognostic test and disease pathogenesis: Host RNA expression profiling by RNA sequencing and proteomic analyses. Cases will be randomly assigned to a Discovery Cohort for identification of diagnostic/prognostic RNA and proteomic profiles).~Disease pathogenesis: Host RNA expression profiling by RNA sequencing and proteomic analyses will be performed to explore disease pathogenesis.

Control group 1

300 children without congenital CMV infection.~Study procedures:~Diagnostic/prognostic test and disease pathogenesis: Host RNA expression profiling by RNA sequencing and proteomic analyses. Cases will be randomly assigned to a Discovery Cohort for identification of diagnostic/prognostic RNA and proteomic profiles).~Disease pathogenesis: Host RNA expression profiling by RNA sequencing and proteomic analyses will be performed to explore disease pathogenesis.

Control group 2

30 neonates with asymptomatic congenital CMV infection and no sequelae~Study procedures:~Diagnostic/prognostic test and disease pathogenesis: Host RNA expression profiling by RNA sequencing and proteomic analyses. Cases will be randomly assigned to a Discovery Cohort for identification of diagnostic/prognostic RNA and proteomic profiles).~Disease pathogenesis: Host RNA expression profiling by RNA sequencing and proteomic analyses will be performed to explore disease pathogenesis.

Related Therapeutic Areas

Cytomegalic Inclusion Disease

Hearing Loss

Congenital Cytomegalovirus

Cytomegalovirus Infection

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