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

• Conditions: Neonatal Sepsis

• Registration Number: NCT01294865
• Lead Sponsor: Ankara University

Brief Summary

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.

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.

Study Timeline

• Status Verified: 2009-12
• Study Start: 2010-01
• Study First Submitted: 2011-02-11
• Study First Submitted QC: 2011-02-11
• Last Update Submitted: 2011-02-11
• Study First Posted: 2011-02-14
• Last Update Posted: 2011-02-14
• Primary Completion: 2012-01
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Infants with late-onset neonatal sepsis

Exclusion Criteria

• Infants without parents' consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Levels of suPAR in late-onset neonatal sepsis	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

Name	Time	Method
Level of plasma C-reactive protein	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	three weeks	the white blood cell counts to confirm the diagnostic usefulness of suPAR measurements at diagnosis and end of the treatment

Trial Locations

Locations (1)

Ankara University Faculty of Medicine, Department of Pediatrics; 🇹🇷 Ankara, Turkey