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
Sponsor:
Information provided by:
Ankara University
ClinicalTrials.gov Identifier:
NCT01294865
First received: February 11, 2011
Last updated: NA
Last verified: December 2009
History: No changes posted
  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 ] [ 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

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

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

Criteria

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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Saadet Arsan, Ankara University
ClinicalTrials.gov 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:
Sepsis
late-onset
suPAR

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014