Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT04763967
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
3 Years
Study:
NCT04763967
Study Brief:
Protocol Section:
NCT04763967