Status:
TERMINATED
A Study of the PedSCath Pediatric Sampling Catheter Versus Current Standard of Care.
Lead Sponsor:
Big Blue Biotech, Inc.
Conditions:
Urinary Tract Infections in Children
Eligibility:
All Genders
Up to 3 years
Brief Summary
This is a retrospectively-controlled clinical trial that will examine the rate of positive UTI cases among pediatrics entered into the Emergency Department and whose urine is withdrawn using the PedSC...
Detailed Description
This will be a multi-center, retrospective-controlled, clinical trial. Anonymized retrospective data from two clinical sites, NewYork-Presbyterian Queens and Weill Cornell Medical College, from 2016 ...
Eligibility Criteria
Inclusion
- Subject is 3 years of age or younger.
- Subject is non-toilet trained, as communicated by subject's parent/guardian.
- Subject is presenting to the emergency department with symptoms for UTI, as described by AAP guidelines (Newborns with UTI may present with jaundice, sepsis, failure to thrive, vomiting, or fever. In infants and young children, typical signs and symptoms include fever, strong-smelling urine, hematuria, abdominal or flank pain, and new-onset urinary incontinence) or as determined by PI.
- Subject's parent/guardian is able to provide informed consent.
Exclusion
- Any subject with known underlying abnormalities to the genitourinary tract (e.g. prenatal hydronephrosis).
- Any subject who has had prior genitourinary tract or abdominal surgery.
- Any subject who is toilet trained (i.e. able to provide a clean catch urine sample).
- Any subject with an active rash or skin lesion in the suprapubic area.
- Any subject with a known allergy to LDPE, Elvax, or Crodamide plastics.
Key Trial Info
Start Date :
August 27 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 2 2023
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04763967
Start Date
August 27 2021
End Date
February 2 2023
Last Update
June 22 2023
Active Locations (1)
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1
NewYork-Presbyterian Queens
New York, New York, United States, 11355