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

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

COMPLETED

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2013-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Nosocomial Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A-1

Proven nosocomial bacterial infection (NBI)

No interventions assigned to this group

A-2

Possible NBI

No interventions assigned to this group

B-1

Absence of NBI

No interventions assigned to this group

B-2

Probable absence of NBI

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

72 Hours

Maximum Eligible Age

90 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No