Study of Protein and RNA Biomarkers in Newborns With and Without Congenital Cytomegalovirus Infection To Improve Diagnosis and Understand Disease Development

What this Trial Is About

Researchers are studying congenital cytomegalovirus CMV infection, a common cause of viral infection in newborns that can lead to permanent disabilities such as hearing loss and developmental delays. The study aims to identify new protein biomarkers and RNA expression patterns in dried blood spot samples to improve early diagnosis and understanding of how the disease develops. This observational research involves children born with and without congenital CMV infection in Denmark from 2010 to 2025. The study includes three groups children with symptomatic CMV infection, children without CMV infection, and neonates with asymptomatic CMV infection who have no lasting symptoms. Researchers will perform RNA sequencing and proteomic analyses on stored neonatal dried blood spot samples to discover diagnostic and prognostic molecular profiles and explore disease mechanisms. Cases will be randomly assigned to a discovery cohort for detailed analysis. Participants are involved by providing access to their neonatal dried blood spot samples collected shortly after birth. The research team will analyze protein and RNA expression differences associated with disease outcomes. Immune pathway activity will also be studied. The study does not involve new treatments but focuses on laboratory analysis of existing samples to improve future diagnosis and prevention of CMV-related complications.

Protein Biomarkers and Host RNA Expression Profiles in Congenital Cytomegalovirus Infection