Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01120678

Enrollment

250

Registered

2010-05-11

Start date

2009-02-28

Completion date

2010-07-31

Last updated

2020-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Sepsis

Keywords

cytokines, neonatal sepsis, diagnosis of sepsis, bacteremia, blood culture, clinical sepsis

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Days to No maximum

Healthy volunteers

Inclusion criteria

* NICU patients \> 3 days of age

Exclusion criteria

* less than 3 days old or no waste blood available

Design outcomes

Primary

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

Secondary

Measure	Time frame
Heart rate characteristics	Within twenty-fours pre and post blood culture.

Countries

United States

Outcome results