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
Sex
ALL
Min age
0 Days
Max age
28 Days
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Differential protein expression associated with sequelae following congenital cytomegalovirus infection — At neonatal dried blood spot sampling (typically 2-3 days after birth). Normalized protein expression levels measured by Olink proteomics in neonatal dried blood spot samples obtained at birth from children with congenital cytomegalovirus infection who subsequently developed sequelae compared with children who did not develop sequelae and healthy controls.
Differential host RNA expression associated with sequelae following congenital cytomegalovirus infection — At neonatal dried blood spot sampling (typically 2-3 days after birth). Host RNA expression profiles measured in neonatal dried blood spot samples obtained at birth from children with congenital cytomegalovirus infection who subsequently developed sequelae compared with children who did not develop sequelae and healthy controls.
Trial sites (2)
Facility
City
Region
Status
Department of Paediatrics and Adolescent Medicine, Rigshospitalet
Copenhagen
Denmark
Recruiting
Department of Congenital Disorders, Statens Serum Institut
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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