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Clinical Trials/NCT02858700
NCT02858700CompletedNot Applicable

Value for Cord Blood Procalcitonin to Diagnose Early Neonatal Bacterial Infection

University Hospital, Montpellier1 site in 1 country550 target enrollmentStarted: April 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
550
Locations
1
Primary Endpoint
value of the procalcitonin in the umbilical cord blood

Study 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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
1 Minute to 30 Minutes (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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 ) .

Arms & Interventions

umbilical cord blood procalcitonin

Experimental

dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP

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

Outcomes

Primary Outcomes

value of the procalcitonin in the umbilical cord blood

Time Frame: up to 1 hour

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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