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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00701948

Acronym

NOSODIAG

Enrollment

240

Registered

2008-06-19

Start date

2008-07-31

Completion date

2013-12-31

Last updated

2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nosocomial Infection

Keywords

Late onset neonatal sepsis, Nosocomial bacterial infection, Inflammatory markers, multiplex dosage

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

72 Hours to 90 Days

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Evaluation of new dosage of inflammatory markers or new inflammatory markers for the diagnosis of nosocomial bacterial infection.	48 hours and at 72 hours

Countries

France

Outcome results