NCT01120678

Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 250 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 3 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Neonatal Sepsis

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2010-05-11
• Last updated: 2020-11-04

Locations

2 sites across 1 country: United States