A Study of the PedSCath Pediatric Sampling Catheter Versus Current Standard of Care.
Stopped early
Conditions studied: Urinary Tract Infections in Children
In brief
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will examine the rate of positive UTI cases among pediatrics entered into the Emergency Department and whose urine is withdrawn using the PedSCath Pediatric Sampling Catheter. The rate of postive UTI will be compared against the control population, whose urine withdrawal would have been performed with Standard of Care devices.
Key facts
- Study ID
- NCT04763967
- Run by
- Big Blue Biotech, Inc.
- People needed
- 2
- Starts
- 2021-08-27
- Expected to finish
- 2023-02-02
- Last updated by the study team
- 2023-06-22
Who can join
Age: any, up to 3. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- NewYork-Presbyterian Queens — New York, New York, United States
Full record on ClinicalTrials.gov
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