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Clinical Trials/NCT02858700
NCT02858700
Completed
Not Applicable

Value for Cord Blood Procalcitonin to Diagnose Early Neonatal Bacterial Infection

University Hospital, Montpellier1 site in 1 country550 target enrollmentApril 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neonatal Bacterial Infection
Sponsor
University Hospital, Montpellier
Enrollment
550
Locations
1
Primary Endpoint
value of the procalcitonin in the umbilical cord blood
Status
Completed
Last Updated
9 years ago

Overview

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:

  1. one source to higher health care costs (hospitalization, additional examinations)
  2. Selection of the bacterial ecology of the newborn and neonatal services and
  3. stress for the newborn and parents
Registry
clinicaltrials.gov
Start Date
April 2009
End Date
December 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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 ) .

Outcomes

Primary Outcomes

value of the procalcitonin in the umbilical cord blood

Time Frame: up to 1 hour

Study Sites (1)

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