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

NCT ID: NCT01294865

Last Updated: 2011-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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Neonatal Sepsis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

non-septic

Infants without any clinical or hematological septic signs. Blood samples will be taken only once.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Infants with late-onset neonatal sepsis

Exclusion Criteria

* Infants without parents' consent
Minimum Eligible Age

4 Days

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Ankara University

Principal Investigators

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Saadet Arsan, Professor

Role: STUDY_DIRECTOR

Ankara University

Locations

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Ankara University Faculty of Medicine, Department of Pediatrics

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Okulu E, Arsan S, Akin IM, Ates C, Alan S, Kilic A, Atasay B. Serum Levels of Soluble Urokinase Plasminogen Activator Receptor in Infants with Late-onset Sepsis. J Clin Lab Anal. 2015 Sep;29(5):347-52. doi: 10.1002/jcla.21777. Epub 2014 Jul 10.

Reference Type DERIVED
PMID: 25043869 (View on PubMed)

Other Identifiers

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Ankara University

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Ankara University-02

Identifier Type: -

Identifier Source: org_study_id

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