- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02858700
Value for Cord Blood Procalcitonin to Diagnose Early Neonatal Bacterial Infection (PCT_CORDON)
After birth, in the presence of risk factors for early neonatal bacterial infection (IBNP), the pediatrician must make a difficult decision quickly or not to prescribe additional examinations and / or hospitalize or not the newborn in order to administer parenteral antibiotics. This decision takes into account several contextual data, (clinical, biological and bacteriological clinical data) to be considered simultaneously. These information lack sensitivity and specificity.
Therefore, the common attitude among newborns in many countries remains the achievement of a significant number of additional tests and the establishment, without a prior evidence of infection, intravenous empirical antibiotic therapy for 48 -72h at least in hospitalization. However, the diagnosis of IBNP posteriori, is often reversed. This attitude is:
- one source to higher health care costs (hospitalization, additional examinations)
- Selection of the bacterial ecology of the newborn and neonatal services and
- stress for the newborn and parents
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Montpellier, France
- University Hospital of Montpellier
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Birth to motherhood.
- Term > 34 weeks .
- Presence of at least one of the factors of major or minor infection risk
Exclusion Criteria:
- cord blood sample unavailable.
- Death in the delivery room
- Corticosteroids prenatally (modification of cytokine production ) .
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: umbilical cord blood procalcitonin
dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
value of the procalcitonin in the umbilical cord blood
Time Frame: up to 1 hour
|
up to 1 hour
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8271 (CTEP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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