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Value for Cord Blood Procalcitonin to Diagnose Early Neonatal Bacterial Infection

Value for Cord Blood Procalcitonin to Diagnose Early Neonatal Bacterial Infection

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02858700
Acronym
PCT_CORDON
Enrollment
550
Registered
2016-08-08
Start date
2009-04-30
Completion date
2015-12-31
Last updated
2016-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Bacterial Infection

Keywords

neonatal bacterial infection, procalcitonin

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

Interventions

BIOLOGICALdosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 30 Minutes
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 ) .

Design outcomes

Primary

MeasureTime frame
value of the procalcitonin in the umbilical cord bloodup to 1 hour

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026