Soluble Urokinase Plasminogen Activator Receptor (suPAR) in Late-onset Neonatal Sepsis
suPAR
The Plasma Levels of suPAR in Late-onset Neonatal Sepsis
2 other identifiers
observational
120
1 country
1
Brief Summary
The purpose of the study is to investigate the plasma levels of Soluble Urokinase Plasminogen Activator Receptor (suPAR) at the diagnosis and after treatment of sepsis, and to determine whether it has a diagnostic and prognostic value in late-onset neonatal sepsis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 11, 2011
CompletedFirst Posted
Study publicly available on registry
February 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFebruary 14, 2011
December 1, 2009
2 years
February 11, 2011
February 11, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Levels of suPAR in late-onset neonatal sepsis
Levels of suPAR will be dosed with suspicion of late-onset sepsis diagnosis at day 0 and at the end of the treatment. The evolution and the best cut-off values will be calculated for the diagnosis. Indices of sensibility, specificity, positive predictive value and negative predictive value will be calculated.
three weeks
Secondary Outcomes (2)
Level of plasma C-reactive protein
three weeks
the white blood cell count
three weeks
Study Arms (2)
septic
Infants having clinical suspected late-onset neonatal sepsis enrolled in the study. Blood samples for suPAR were obtained before initiating antibiotic treatment and at the end of the treatment with other laboratory tests.
non-septic
Infants without any clinical or hematological septic signs. Blood samples will be taken only once.
Eligibility Criteria
Infants in Ankara University neonatal intensive care unit
You may qualify if:
- Infants with late-onset neonatal sepsis
You may not qualify if:
- Infants without parents' consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara University Faculty of Medicine, Department of Pediatrics
Ankara, 06620, Turkey (Türkiye)
Related Publications (1)
Okulu E, Arsan S, Akin IM, Ates C, Alan S, Kilic A, Atasay B. Serum Levels of Soluble Urokinase Plasminogen Activator Receptor in Infants with Late-onset Sepsis. J Clin Lab Anal. 2015 Sep;29(5):347-52. doi: 10.1002/jcla.21777. Epub 2014 Jul 10.
PMID: 25043869DERIVED
Biospecimen
Serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Saadet Arsan, Professor
Ankara University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 11, 2011
First Posted
February 14, 2011
Study Start
January 1, 2010
Primary Completion
January 1, 2012
Study Completion
June 1, 2012
Last Updated
February 14, 2011
Record last verified: 2009-12