Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay
- Conditions
- Neonatal Sepsis
- Registration Number
- NCT01120678
- Lead Sponsor
- University of Virginia
- Brief Summary
The purpose of this study is to determine whether analysis of specific serum biomarkers will improve the diagnosis of late onset neonatal sepsis and to determine the correlation between plasma levels of specific cytokines and bacteremia in NICU patients \>3 days of age.
- Detailed Description
All infants in the Newborn Intensive Care Unit greater than three days old that had blood cultures sent were eligible for this study. Left-over blood from the time at blood culture was collected for research purposes. Study personnel separated the serum and stored samples at -80 degrees until analysis. Samples were analyzed in batch for neonatal sepsis biomarkers using an antibody-coated microsphere assay with dual laser detection. Clinical information collected included symptoms prompting the blood culture, CBC and culture results, and antibiotic therapy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- NICU patients > 3 days of age
- less than 3 days old or no waste blood available
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cytokine response Within the first twenty-four hours after blood cultures are obtained.
- Secondary Outcome Measures
Name Time Method Heart rate characteristics Within twenty-fours pre and post blood culture.
Trial Locations
- Locations (2)
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
University of Virginia Neonatal Intensive Care Unit
🇺🇸Charlottesville, Virginia, United States