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Value for Cord Blood Procalcitonin to Diagnose Early Neonatal Bacterial Infection (PCT_CORDON)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Neonatal Bacterial Infection

Treatments

Biological: dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

550 patients

Sex

All

Ages

1 to 30 minutes old

Volunteers

Accepts 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 ) .

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

550 participants in 1 patient group

umbilical cord blood procalcitonin
Experimental group
Description:
dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP
Treatment:
Biological: dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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