Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay
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.
Late Onset Neonatal Sepsis
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay|
- Cytokine response [ Time Frame: Within the first twenty-four hours after blood cultures are obtained. ] [ Designated as safety issue: No ]
- Heart rate characteristics [ Time Frame: Within twenty-fours pre and post blood culture. ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Samples of whole blood were obtained and processed to collect and retain only serum.
|Study Start Date:||February 2009|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
|Neonates assessed for sepsis.|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120678
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston Salem, North Carolina, United States, 27157|
|United States, Virginia|
|University of Virginia Neonatal Intensive Care Unit|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Karen Fairchild, MD||University of Virginia School of Medicine|