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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
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neonatal Bacterial Infection focused on measuring neonatal bacterial infection, procalcitonin

Eligibility Criteria

1 Minute - 30 Minutes (Child)All SexesAccepts Healthy Volunteers

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

First Posted
July 21, 2016
Last Updated
August 5, 2016
Sponsor
University Hospital, Montpellier
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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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