Soluble Urokinase Plasminogen Activator Receptor (suPAR) in Late-onset Neonatal Sepsis
Recruitment status was Active, not recruiting
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||The Plasma Levels of suPAR in Late-onset Neonatal Sepsis|
- 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.
- 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
|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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294865
|Ankara University Faculty of Medicine, Department of Pediatrics|
|Ankara, Turkey, 06620|
|Study Director:||Saadet Arsan, Professor||Ankara University|