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

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ClinicalTrials.gov Identifier: NCT01294865
Recruitment Status : Unknown
Verified December 2009 by Ankara University.
Recruitment status was:  Active, not recruiting
First Posted : February 14, 2011
Last Update Posted : February 14, 2011
Information provided by:
Ankara University

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.

Condition or disease
Neonatal Sepsis

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.

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Plasma Levels of suPAR in Late-onset Neonatal Sepsis
Study Start Date : January 2010
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

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.
Infants without any clinical or hematological septic signs. Blood samples will be taken only once.

Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

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

Inclusion Criteria:

  • Infants with late-onset neonatal sepsis

Exclusion Criteria:

  • Infants without parents' consent

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

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

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 Posted: February 14, 2011    Key Record Dates
Last Update Posted: February 14, 2011
Last Verified: December 2009

Keywords provided by Ankara University:

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