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Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay

NCT ID: NCT01120678

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neonatal Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neonates assessed for sepsis.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* NICU patients \> 3 days of age

Exclusion Criteria

* less than 3 days old or no waste blood available
Minimum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wallace H. Coulter Foundation

OTHER

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Karen Fairchild, MD

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen Fairchild, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia School of Medicine

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

University of Virginia Neonatal Intensive Care Unit

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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13987

Identifier Type: -

Identifier Source: org_study_id