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NCT01120678 Clinical Trial

Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay

Neonatal Sepsis Clinical Trial

Official title:
Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01120678
Other study ID # 13987
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2009
Est. completion date July 2010

Study information
Verified date November 2020
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 250
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - NICU patients > 3 days of age Exclusion Criteria: - less than 3 days old or no waste blood available

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Virginia Neonatal Intensive Care Unit Charlottesville Virginia
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (2)
Lead Sponsor Collaborator
University of Virginia Wallace H. Coulter Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cytokine response Within the first twenty-four hours after blood cultures are obtained.
Secondary Heart rate characteristics Within twenty-fours pre and post blood culture.
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