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Soluble Urokinase Plasminogen Activator Receptor (suPAR) in Late-onset Neonatal Sepsis (suPAR)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by Ankara University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01294865
First Posted: February 14, 2011
Last Update Posted: February 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ankara University
  Purpose
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.

Condition
Neonatal Sepsis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Plasma Levels of suPAR in Late-onset Neonatal Sepsis

Resource links provided by NLM:


Further study details as provided by Ankara University:

Primary Outcome Measures:
  • Levels of suPAR in late-onset neonatal sepsis [ Time Frame: three weeks ]
    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.


Secondary Outcome Measures:
  • Level of plasma C-reactive protein [ Time Frame: three weeks ]
    Plasma C-reactive protein levels to confirm the diagnostic usefulness of suPAR measurements at diagnosis and end of the treatment

  • the white blood cell count [ Time Frame: three weeks ]
    the white blood cell counts to confirm the diagnostic usefulness of suPAR measurements at diagnosis and end of the treatment


Biospecimen Retention:   Samples Without DNA
Serum

Estimated Enrollment: 120
Study Start Date: January 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:
Infection is a leading cause of neonatal morbidity and mortality worldwide. The clinical presentation of neonatal infection is subtle and nonspecific. Microbiologic cultures of clinical specimens, the gold standard for diagnosis, have low sensitivity and are not available in time to influence initial therapy. Therefore, reliable and rapid in vitro tests are needed for early diagnosis and management of infection in neonates. suPAR, secreted from the cells (neutrophils, lymphocytes, macrophages, endothelial cells) has recently been reported to be a potential biomarker for several infection diseases. The levels of suPAR have not been studied in newborn infants yet.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Infants in Ankara University neonatal intensive care unit
Criteria

Inclusion Criteria:

  • Infants with late-onset neonatal sepsis

Exclusion Criteria:

  • Infants without parents' consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01294865


Locations
Turkey
Ankara University Faculty of Medicine, Department of Pediatrics
Ankara, Turkey, 06620
Sponsors and Collaborators
Ankara University
Investigators
Study Director: Saadet Arsan, Professor Ankara University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Saadet Arsan, Ankara University
ClinicalTrials.gov Identifier: NCT01294865     History of Changes
Other Study ID Numbers: Ankara University-02
Ankara University ( Other Grant/Funding Number: Ankara University Research Fund (10B3330012) )
First Submitted: February 11, 2011
First Posted: February 14, 2011
Last Update Posted: February 14, 2011
Last Verified: December 2009

Keywords provided by Ankara University:
Sepsis
late-onset
suPAR

Additional relevant MeSH terms:
Sepsis
Toxemia
Neonatal Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Infant, Newborn, Diseases