Value for Cord Blood Procalcitonin to Diagnose Early Neonatal Bacterial Infection

Not Applicable

Completed

• Conditions: Neonatal Bacterial Infection
• Interventions: Biological: dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP

• Registration Number: NCT02858700
• Lead Sponsor: University Hospital, Montpellier

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted: 2016-07-21
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-05
• Last Update Submitted: 2016-08-05
• Study First Posted: 2016-08-08
• Last Update Posted: 2016-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 550

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 ) .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
umbilical cord blood procalcitonin	dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP	dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP

Primary Outcome Measures

Name	Time	Method
value of the procalcitonin in the umbilical cord blood	up to 1 hour

Trial Locations

Locations (1)

University hospital of Montpellier; 🇫🇷 Montpellier, France