This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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
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 ]
    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

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   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Saadet Arsan, Ankara University Identifier: NCT01294865     History of Changes
Other Study ID Numbers: Ankara University-02
Ankara University ( Other Grant/Funding Number: Ankara University Research Fund (10B3330012) )
Study First Received: February 11, 2011
Last Updated: February 11, 2011

Keywords provided by Ankara University:

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes processed this record on June 23, 2017