Status:
UNKNOWN
Neonatal Procalcitonin Intervention Study
Lead Sponsor:
Luzerner Kantonsspital
Collaborating Sponsors:
Kantonsspital Winterthur KSW
Triemli Hospital
Conditions:
Sepsis
Eligibility:
All Genders
Up to 3 years
Phase:
NA
Brief Summary
In neonates, clinical signs and symptoms associated with early-onset sepsis are non-specific and currently available tests have poor positive and negative predictive values. The investigators hypothes...
Detailed Description
Detailed description according our pilot study (see reference). This trial is designed to exclude a difference in rate of re-infection or death greater than 2%. Assuming a 2% reinfection/death rate in...
Eligibility Criteria
Inclusion
- Term and near term infants with a gestational age \> 34 weeks
- Suspected sepsis in the first 3 days of life requiring empiric antibiotic therapy
- Parental consent
Exclusion
- Surgery in the first week of life
- Severe congenital malformations
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2016
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT00854932
Start Date
June 1 2009
End Date
August 1 2016
Last Update
March 8 2016
Active Locations (1)
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1
children's Hospital of Lucerne
Lucerne, Switzerland, 6000