Host RNA Expression Profiles and Protein Biomarkers in Neonatal Herpes Simplex Virus Infection

NCT05226949 | Completed

• 1 other identifier: H-21009288-HSV
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 2

Brief Summary

This study seeks to identify and test host RNA expression profiles in context to protein biomarkers in dried blood spot samples as novel diagnostic markers of neonatal herpes simplex virus infection and to improve the understanding of the pathogenesis of the disease.

Conditions

Neonatal Herpes Simplex Infection; Neonatal HSV Infection; Neonatal Infection; Newborn; Infection; Herpes Simplex Virus Infection; Neonatal Sepsis; Neonatal Death; Viral Infection

Outcome Measures

Primary Outcomes (1)

• Host RNA expression and proteomic profiles

  To identify specific host RNA expression and proteomic profiles in dried blood spot samples from newborns with HSV infection

  Admission, age 0-28 days

Secondary Outcomes (2)

• Disease pathogenesis

  Admission, age 0-28 days

• Application of known host RNA profiles

  Admission, age 0-28 days

Study Arms (2)

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).

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).

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborns aged 0-28 days with verified HSV infection in Denmark from 2010 through 2019.

You may qualify if:

• cases of newborns aged 0-28 days with verified HSV infection (positive HSV PCR in blood, cerebrospinal fluid and/or swab sample)
• controls of newborns without infection matched on gestational age, sex and birthweight

You may not qualify if:

• dried blood spot samples that are not allowed to be used for research
• dried blood spots samples containing insufficient amount of blood for research

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Statens Serum Institut: collaborator

Study Sites (2)

Department of Paediatrics and Adolescent Medicine, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Department of Congenital Disorders, Statens Serum Institut

Copenhagen, 2300, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Dried blood spot samples will be obtained from the Danish Neonatal Screening Biobank, Statens Serum Institut. RNA sequencing and proteomic analyses (in total 12 ul whole blood) will be performed at the Danish Center for Neonatal Screening, Department of Congenital Disorders, Statens Serum Institut.

MeSH Terms

Conditions

Neonatal herpes; Infections; Herpes Simplex; Neonatal Sepsis; Perinatal Death; Virus Diseases

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Sepsis; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death

Study Officials

• Kia Hee Schultz Dungu, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Ulrikka Nygaard, Ass Prof PhD

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 7, 2022
• Study Start: January 1, 2022
• Primary Completion: February 28, 2022
• Study Completion: April 30, 2022
• Last Updated: December 28, 2022

Record last verified: 2022-12

Locations

DK (2)