NCT01120678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 11, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

1.4 years

First QC Date

May 7, 2010

Last Update Submit

November 2, 2020

Conditions

Neonatal Sepsis

Keywords

cytokinesneonatal sepsisdiagnosis of sepsisbacteremiablood cultureclinical sepsis

Outcome Measures

Primary Outcomes (1)

  • Cytokine response

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

Secondary Outcomes (1)

  • Heart rate characteristics

    Within twenty-fours pre and post blood culture.

Study Arms (1)

Neonates assessed for sepsis.

Eligibility Criteria

Age3 Days+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • NICU patients \> 3 days of age

You may not qualify if:

  • less than 3 days old or no waste blood available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

University of Virginia Neonatal Intensive Care Unit

Charlottesville, Virginia, 22908, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples of whole blood were obtained and processed to collect and retain only serum.

MeSH Terms

Conditions

Neonatal SepsisBacteremia

Condition Hierarchy (Ancestors)

SepsisInfectionsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsBacterial InfectionsBacterial Infections and Mycoses

Study Officials

  • Karen Fairchild, MD

    University of Virginia School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

May 7, 2010

First Posted

May 11, 2010

Study Start

February 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

November 4, 2020

Record last verified: 2020-11

Locations

US(2)