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Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay

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ClinicalTrials.gov Identifier: NCT01120678
Recruitment Status : Completed
First Posted : May 11, 2010
Last Update Posted : March 7, 2011
Information provided by:

Study Description
Brief 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.

Condition or disease
Late Onset Neonatal 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.

Study Design

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay
Study Start Date : February 2009
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Groups and Cohorts

Neonates assessed for sepsis.

Outcome Measures

Primary Outcome Measures :
  1. Cytokine response [ Time Frame: Within the first twenty-four hours after blood cultures are obtained. ]

Secondary Outcome Measures :
  1. Heart rate characteristics [ Time Frame: Within twenty-fours pre and post blood culture. ]

Biospecimen Retention:   Samples Without DNA
Samples of whole blood were obtained and processed to collect and retain only serum.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

Inclusion Criteria:

  • NICU patients > 3 days of age

Exclusion Criteria:

  • less than 3 days old or no waste blood available
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Sponsors and Collaborators
University of Virginia
Wallace H. Coulter Foundation
Principal Investigator: Karen Fairchild, MD University of Virginia School of Medicine
More Information

Responsible Party: Karen Fairchild, MD, University of Virginia School of Medicine
ClinicalTrials.gov Identifier: NCT01120678     History of Changes
Other Study ID Numbers: 13987
First Posted: May 11, 2010    Key Record Dates
Last Update Posted: March 7, 2011
Last Verified: March 2011

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

Additional relevant MeSH terms:
Neonatal Sepsis
Systemic Inflammatory Response Syndrome
Pathologic Processes
Infant, Newborn, Diseases