Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay

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.

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Key information

Conditions

Neonatal SEPSIS Bacteremia Bacterial Infections Bacterial Infections and Mycoses Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

3 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

NICU patients > 3 days of age

Exclusion criteria

less than 3 days old or no waste blood available

Treatment and study plan

Primary outcomes

Cytokine response

Time frame: Within the first twenty-four hours after blood cultures are obtained.

Secondary outcomes

Heart rate characteristics

Time frame: Within twenty-fours pre and post blood culture.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

Wallace H. Coulter Foundation

Registry information

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: May 11, 2010
Registry last updated: Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed