Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay

This study has been completed.
Sponsor:
Collaborator:
Wallace H. Coulter Foundation
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT01120678
First received: May 7, 2010
Last updated: March 4, 2011
Last verified: March 2011

May 7, 2010
March 4, 2011
February 2009
July 2010   (final data collection date for primary outcome measure)
Cytokine response [ Time Frame: Within the first twenty-four hours after blood cultures are obtained. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01120678 on ClinicalTrials.gov Archive Site
Heart rate characteristics [ Time Frame: Within twenty-fours pre and post blood culture. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Samples of whole blood were obtained and processed to collect and retain only serum.

Probability Sample

Infants in the Newborn Intensive Care Unit greater than three days of age undergoing sepsis evaluation.

Late Onset Neonatal Sepsis
Not Provided
Neonates assessed for sepsis.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • NICU patients > 3 days of age

Exclusion Criteria:

  • less than 3 days old or no waste blood available
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01120678
13987
No
Karen Fairchild, MD, University of Virginia School of Medicine
University of Virginia
Wallace H. Coulter Foundation
Principal Investigator: Karen Fairchild, MD University of Virginia School of Medicine
University of Virginia
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP