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
  Purpose

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.


Condition
Late Onset Neonatal Sepsis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Cytokine response [ Time Frame: Within the first twenty-four hours after blood cultures are obtained. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 250
Study Start Date: February 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Neonates assessed for sepsis.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • NICU patients > 3 days of age

Exclusion Criteria:

  • less than 3 days old or no waste blood available
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120678

Locations
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
Sponsors and Collaborators
University of Virginia
Wallace H. Coulter Foundation
Investigators
Principal Investigator: Karen Fairchild, MD University of Virginia School of Medicine
  More Information

No publications provided

Responsible Party: Karen Fairchild, MD, University of Virginia School of Medicine
ClinicalTrials.gov Identifier: NCT01120678     History of Changes
Other Study ID Numbers: 13987
Study First Received: May 7, 2010
Last Updated: March 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
cytokines
late-onset neonatal sepsis
neonatal sepsis
diagnosis of sepsis
bacteremia
blood culture
clinical sepsis

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014