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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Ankara University.
Recruitment status was  Active, not recruiting
Information provided by:
Ankara University Identifier:
First received: February 11, 2011
Last updated: NA
Last verified: December 2009
History: No changes posted

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.

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


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)
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.

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.


Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01294865

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

No publications provided

Responsible Party: Saadet Arsan, Ankara University Identifier: NCT01294865     History of Changes
Other Study ID Numbers: Ankara University-02, Ankara University
Study First Received: February 11, 2011
Last Updated: February 11, 2011
Health Authority: Turkey: Ethics Committee

Keywords provided by Ankara University:

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes processed this record on October 19, 2014