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

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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Key information

Conditions

Nosocomial Infection Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cross Infection Disease Attributes Iatrogenic Disease Infant, Newborn, Diseases Infections Inflammation Neonatal Sepsis Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

72 hour–90 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Pédiatrie 2 - Hôpital d'Enfants CHU de Dijon; 10 - bld Maréchal de Lattre de Tassigny, Dijon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: NOSODIAG

Important dates

Study start: 2008
Primary completion: 2013
Study completion: 2013
First posted: Jun 19, 2008
Registry last updated: Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed