Value for Cord Blood Procalcitonin to Diagnose Early Neonatal Bacterial Infection (PCT_CORDON)
Primary Purpose
Neonatal Bacterial Infection
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP
Sponsored by
About this trial
This is an interventional diagnostic trial for Neonatal Bacterial Infection focused on measuring neonatal bacterial infection, procalcitonin
Eligibility Criteria
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 ) .
Sites / Locations
- University hospital of Montpellier
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
umbilical cord blood procalcitonin
Arm Description
dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP
Outcomes
Primary Outcome Measures
value of the procalcitonin in the umbilical cord blood
Secondary Outcome Measures
Full Information
NCT ID
NCT02858700
First Posted
July 21, 2016
Last Updated
August 5, 2016
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02858700
Brief Title
Value for Cord Blood Procalcitonin to Diagnose Early Neonatal Bacterial Infection
Acronym
PCT_CORDON
Official Title
Value for Cord Blood Procalcitonin to Diagnose Early Neonatal Bacterial Infection
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Bacterial Infection
Keywords
neonatal bacterial infection, procalcitonin
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
550 (Actual)
8. Arms, Groups, and Interventions
Arm Title
umbilical cord blood procalcitonin
Arm Type
Experimental
Arm Description
dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP
Intervention Type
Biological
Intervention Name(s)
dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP
Primary Outcome Measure Information:
Title
value of the procalcitonin in the umbilical cord blood
Time Frame
up to 1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
30 Minutes
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 ) .
Facility Information:
Facility Name
University hospital of Montpellier
City
Montpellier
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Value for Cord Blood Procalcitonin to Diagnose Early Neonatal Bacterial Infection
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