Soluble Urokinase Plasminogen Activator Receptor (suPAR) in Late-onset Neonatal Sepsis
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition |
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Neonatal Sepsis |
| Study Type: | Observational |
| 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
Serum
| Estimated Enrollment: | 120 |
| 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) |
| Groups/Cohorts |
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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.
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non-septic
Infants without any clinical or hematological septic signs. Blood samples will be taken only once.
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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.
Eligibility| Ages Eligible for Study: | up to 1 Month |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Infants in Ankara University neonatal intensive care unit
Inclusion Criteria:
- Infants with late-onset neonatal sepsis
Exclusion Criteria:
- Infants without parents' consent
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Saadet Arsan, Ankara University |
| ClinicalTrials.gov Identifier: | NCT01294865 History of Changes |
| Other Study ID Numbers: | Ankara University-02, Ankara University |
| Study First Received: | February 11, 2011 |
| Last Updated: | February 11, 2011 |
| Health Authority: | Turkey: Ethics Committee |
Keywords provided by Ankara University:
|
Sepsis late-onset suPAR |
Additional relevant MeSH terms:
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Sepsis Toxemia Infection |
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013