Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay

November 2, 2020 updated by: Karen Fairchild, MD, University of Virginia
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Neonatal Intensive Care Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 days and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • NICU patients > 3 days of age

Exclusion Criteria:

  • less than 3 days old or no waste blood available

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Neonates assessed for sepsis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cytokine response
Time Frame: Within the first twenty-four hours after blood cultures are obtained.
Within the first twenty-four hours after blood cultures are obtained.

Secondary Outcome Measures

Outcome Measure
Time Frame
Heart rate characteristics
Time Frame: Within twenty-fours pre and post blood culture.
Within twenty-fours pre and post blood culture.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

Wallace H. Coulter Foundation

Investigators

  • Principal Investigator: Karen Fairchild, MD, University of Virginia School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

May 7, 2010

First Submitted That Met QC Criteria

May 7, 2010

First Posted (Estimate)

May 11, 2010

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13987

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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