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

Overview

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.

Full Title of Study: “The Plasma Levels of suPAR in Late-onset Neonatal Sepsis”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2012

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.

Arms, Groups and 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.

Clinical Trial Outcome Measures

Primary 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 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

Participating in This Clinical Trial

Inclusion Criteria

  • Infants with late-onset neonatal sepsis Exclusion Criteria:

  • Infants without parents' consent

Gender Eligibility: All

Minimum Age: 4 Days

Maximum Age: 1 Month

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ankara University
  • Provider of Information About this Clinical Study
    • Saadet Arsan, Ankara University
  • Overall Official(s)
    • Saadet Arsan, Professor, Study Director, Ankara University

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