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Clinical Trials/NCT00701948
NCT00701948
Completed
Not Applicable

Interest of New Dosages of Inflammatory Markers for the Early Diagnosis of Nosocomial Bacterial Infections of the Newborn

University Hospital, Strasbourg, France2 sites in 1 country240 target enrollmentJuly 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nosocomial Infection
Sponsor
University Hospital, Strasbourg, France
Enrollment
240
Locations
2
Primary Endpoint
Evaluation of new dosage of inflammatory markers or new inflammatory markers for the diagnosis of nosocomial bacterial infection.
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This study aims to evaluate new dosage of inflammatory markers or new inflammatory markers for the diagnosis of nosocomial bacterial infection. We made the hypothesis that these new dosages or new inflammatory markers could be more useful than dosage of inflammatory markers already used in clinical practice (especially the use of a combination of interleukins (6 or 8) and C-reactive protein for the management of newborns with a clinical suspicion of nosocomial bacterial infection and especially could allow to avoid excessive treatment with antibiotics

Registry
clinicaltrials.gov
Start Date
July 2008
End Date
December 2013
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Strasbourg, France
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Newborns \> 72 hours of life hospitalized in neonatal intensive or intermediate care unit presenting a clinical suspicion of NBI

Exclusion Criteria

  • Early post-operative period ( surgery of less than 48 hours)
  • Multiple malformations
  • Newborn already included in the study for a previous septic events
  • Newborn treated with antibiotics in the last 24 hours

Outcomes

Primary Outcomes

Evaluation of new dosage of inflammatory markers or new inflammatory markers for the diagnosis of nosocomial bacterial infection.

Time Frame: 48 hours and at 72 hours

Study Sites (2)

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