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Protein Biomarkers and Host RNA Expression Profiles in Congenital Cytomegalovirus Infection

Recruitingn/aAges 0 Days - 28 DaysAllCopenhagen University Hospital, Rigshospitalet
NCT07635368 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

2 sites
Department of Paediatrics and Adolescent Medicine, Rigshospitalet
Copenhagen, Denmark
Department of Congenital Disorders, Statens Serum Institut
Copenhagen, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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