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Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay

Sponsor
University of Virginia (Other)
Overall Status
Completed
CT.gov ID
NCT01120678
Collaborator
Wallace H. Coulter Foundation (Other)
250
Enrollment
2
Locations
16.9
Duration (Months)
125
Patients Per Site
7.4
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase

    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
    Actual Enrollment :
    250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay
    Study Start Date :
    Feb 1, 2009
    Actual Primary Completion Date :
    Jul 1, 2010
    Actual Study Completion Date :
    Jul 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Neonates assessed for sepsis.

    Outcome Measures

    Primary Outcome Measures

    1. Cytokine response [Within the first twenty-four hours after blood cultures are obtained.]

    Secondary Outcome Measures

    1. Heart rate characteristics [Within twenty-fours pre and post blood culture.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Days and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • NICU patients > 3 days of age
    Exclusion Criteria:
    • less than 3 days old or no waste blood available

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    2 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Karen Fairchild, MD, Professor of Pediatrics, University of Virginia
    ClinicalTrials.gov Identifier:
    NCT01120678
    Other Study ID Numbers:
    • 13987
    First Posted:
    May 11, 2010
    Last Update Posted:
    Nov 4, 2020
    Last Verified:
    Nov 1, 2020
    Keywords provided by Karen Fairchild, MD, Professor of Pediatrics, University of Virginia
    cytokines
    neonatal sepsis
    diagnosis of sepsis
    bacteremia
    blood culture
    clinical sepsis
    Additional relevant MeSH terms:
    Sepsis
    Toxemia
    Neonatal Sepsis

    Study Results

    No Results Posted as of Nov 4, 2020