Host RNA Expression Profiles and Protein Biomarkers in Neonatal Herpes Simplex Virus Infection
NCT ID: NCT05226949
Last Updated: 2022-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
159 participants
OBSERVATIONAL
2022-01-01
2022-04-30
Brief Summary
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Detailed Description
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Herpes Simplex Virus (HSV) infection in newborns is uncommon but can be devastating and is associated with significant morbidity and mortality. The diagnosis of neonatal HSV infection is challenging because maternal genital herpes often is asymptomatic and the clinical presentation in newborns can be nonspecific, especially in the early disease stages. This results in late diagnosis and potentially terrible consequences for the newborn. The reason why some newborns develop severe disease due to HSV infection is unknown. It has been suggested that immunologic differences in early infancy are the key to further advances. Host RNA expression profiling, transcriptomics, of the host response to infections has shown great potential as clinical tool for diagnostics and for unveiling molecular disease mechanisms. As previously shown, reliable host RNA expression data can be obtained from neonatal dried blood spot (DBS) samples by RNA-sequencing. Proteomic analysis has the potential to simultaneously identify hundreds of protein biomarkers and immune cell populations allowing for detailed mapping of disease immunological pathways.
Method:
A nationwide retrospective case-control study of all newborns with HSV infection in Denmark from 2010 through 2019. DBS samples will be obtained from the Danish Neonatal Screening Biobank, Statens Serum Institut. RNA sequencing and proteomic analyses will be performed at the Danish Center for Neonatal Screening, Department of Congenital Disorders, Statens Serum Institut. Cases will be randomly assigned to a "Discovery cohort" and compared to a control group of newborns matched on gestational age, sex and birthweight will be included.
Time frame:
Sample identification/recruiting: January 1st to January 31st 2022. Sample analysis (RNA sequencing and proteomic analysis): February 1st to April 30th 2022.
Perspectives:
New molecular-based diagnostic tools complementary to conventional methods may improve early diagnosis of neonatal HSV infections and lead to optimised management. In addition, understanding of the pathogenesis at a molecular level of severe disease manifestations of the disease, could form the basis for development of novel interventions for better prevention and treatment.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Cases
54 newborns with neonatal HSV infection.
Interventions:
Diagnostic test and disease pathogenesis: Host RNA expression profiling by RNA sequencing and proteomic analyses. Cases will be randomly assigned to a "Discovery Cohort" (identification of diagnostic RNA and proteomic profiles).
No interventions assigned to this group
Controls
108 newborns without infection.
Interventions:
Diagnostic test and disease pathogenesis: Host RNA expression profiling by RNA sequencing and proteomic analyses. Controls will be randomly assigned to a "Discovery Cohort" (identification of diagnostic RNA and proteomic profiles).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. controls of newborns without infection matched on gestational age, sex and birthweight
Exclusion Criteria
2. dried blood spots samples containing insufficient amount of blood for research
0 Days
28 Days
ALL
No
Sponsors
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Statens Serum Institut
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
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Kia Hee Schultz Dungu
Principal Investigator
Principal Investigators
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Kia Hee Schultz Dungu, MD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Ulrikka Nygaard, Ass Prof PhD
Role: STUDY_CHAIR
Rigshospitalet, Denmark
Locations
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Department of Paediatrics and Adolescent Medicine, Rigshospitalet
Copenhagen, , Denmark
Department of Congenital Disorders, Statens Serum Institut
Copenhagen, , Denmark
Countries
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Other Identifiers
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H-21009288-HSV
Identifier Type: -
Identifier Source: org_study_id