N39.0
Conditions
Interventions
Group 1: Urine collection and concommitant detection of nitrites and leukocytes by the device U-Lab diapers/U-Test
Group 2: control arm with reference methode: Urine collection with urine bag or other
Sponsors
Swiss Medical Solution AG
Eligibility
Sex/Gender
All
Age
0 Years to 5 Years
Inclusion criteria
Inclusion criteria: - Diaper wearing children under the age of five
Exclusion criteria
Exclusion criteria: - Infants in critical health, for which the application of U-Lab Diapers could interfere with the healing process: Specifically children that present skin lesions or dermatological problems in the genital or sitting area.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) The test can function under real condition with patients. Enough urine enters the test chamber. The test is evaluated after the child has urinated or after 3h at the latest Measurement: The color chance of the validity indicator from green to orange. The color change is reported in the case report form. The percentage of functioning tests is calculated at the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Device gives the same conclusion than the Reference method (dipstick measurements performed with bag urine etc). Measurement: The color change of the nitrite und leukocyte indicators in the new test system and on the reference dipstick, respectively. The results are reported in the case report form. Performance parameters of sensitivity and specificity are calculated 2)The Patients show no skin irritation or other undesired side effect due to the new test device. Measurement: Observation by the responsible phyisician. The observations of the presence or absence of undesired effects are reported in the case report forms. | — |
Countries
Switzerland
Contacts
Public ContactJean-Daniel Krähenbühl
Paediatician office Dr. Krähenbühl
Outcome results
None listed