This trial is active, not recruiting.

Condition neonatal sepsis
Sponsor Ankara University
Start date January 2010
End date January 2012
Trial size 120 participants
Trial identifier NCT01294865, Ankara University, Ankara University-02


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
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.

Primary Outcomes

Levels of suPAR in late-onset neonatal sepsis
time frame: three weeks

Secondary Outcomes

Level of plasma C-reactive protein
time frame: three weeks
the white blood cell count
time frame: three weeks

Eligibility Criteria

Male or female participants up to 1 month old.

Inclusion Criteria: - Infants with late-onset neonatal sepsis Exclusion Criteria: - Infants without parents' consent

Additional Information

Official title The Plasma Levels of suPAR in Late-onset Neonatal Sepsis
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2011.
Information provided to ClinicalTrials.gov by Ankara University.