The Plasma Levels of suPAR in Late-onset Neonatal Sepsis
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Ankara University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Levels of suPAR in late-onset neonatal sepsis
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 4 Days to 1 Month (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Infants with late-onset neonatal sepsis
Exclusion Criteria
- •Infants without parents' consent
Outcomes
Primary Outcomes
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 Outcomes
- Level of plasma C-reactive protein(three weeks)
- the white blood cell count(three weeks)