Status:
COMPLETED
Early Diagnosis of Candidiasis in Premature Infants
Lead Sponsor:
NICHD Neonatal Research Network
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Infection
Candida
Eligibility:
All Genders
3-120 years
Brief Summary
This observational study evaluated the performance of new lab tests in detecting candida species fungal infections in extremely low birth weight (ELBW) infants quickly and accurately. 19 NICHD Neonata...
Detailed Description
Candida species are a leading cause of infectious mortality in newborns with the incidence rates estimated at 4-18% in extremely low birth weight (ELBW) infants. 20-30% of these infants are likely to ...
Eligibility Criteria
Inclusion
- Infants born ≤1,000g birth weight
- Infants \>72 hours old and less than 120 days old
Exclusion
- Prior positive blood culture for Candida
- Evidence of congenital candidiasis
- Parents/legal guardians refuse consent
Key Trial Info
Start Date :
March 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT00109525
Start Date
March 1 2004
End Date
December 1 2009
Last Update
March 22 2019
Active Locations (20)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Stanford University
Palo Alto, California, United States, 94304
3
University of California at San Diego
San Diego, California, United States, 92103-8774
4
Yale University
New Haven, Connecticut, United States, 06504