Value for Cord Blood Procalcitonin to Diagnose Early Neonatal Bacterial Infection

Neonatal Bacterial Infection Clinical Trial

— PCT_CORDON  

Official title:

Value for Cord Blood Procalcitonin to Diagnose Early Neonatal Bacterial Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02858700
• Other study ID #: 8271
• Status: Completed
• Phase: N/A
• First received: July 21, 2016
• Last updated: August 5, 2016
• Start date: April 2009
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 30 Minutes

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infection
• Neonatal Bacterial Infection

Intervention

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

Locations

Country	Name	City	State
France	University hospital of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	value of the procalcitonin in the umbilical cord blood		up to 1 hour	No