Performance Evaluation of U-Lab Diapers; A new screening method for urinary tract infections in diaper wearing childre
Not Applicable
- Conditions
- N39.0Urinary tract infection, site not specified
- Registration Number
- DRKS00003143
- Lead Sponsor
- Swiss Medical Solution AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 68
Inclusion Criteria
Diaper wearing children under the age of five
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br>Measurement: The color chance of the validity indicator from green to orange. The color change is reported in the case report form.<br>The percentage of functioning tests is calculated at the end of the study.<br><br>
- Secondary Outcome Measures
Name Time Method 1)Device gives the same conclusion than the Reference method (dipstick measurements performed with bag urine etc). <br>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<br><br>2)The Patients show no skin irritation or other undesired side effect due to the new test device.<br>Measurement: Observation by the responsible phyisician. The observations of the presence or absence of undesired effects are reported in the case report forms.<br><br><br>