Clinical evaluation of a new sweat test system in the diagnosis of cystic fibrosis after newborn screening
Recruiting
- Conditions
- Cystic Fibrosis1001567410010613
- Registration Number
- NL-OMON32874
- Lead Sponsor
- Atrium Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Newborns referred to the hospital for a sweat test after newborn screening. Children aged less than 2 months with a suspected diagnosis of Cystic Fibrosis. Informed consent has been obtained from the parents.
Exclusion Criteria
Newborns with severe eczema, sepsis or dehydration (sweat test results are not reliable). Infants with meconium ileus. Informed consent can not be obtained.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Succes rate of the Nanoduct system.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Sensitivity, specificity, upper and lower cut-off values, time to diagnosis.</p><br>