To determine the reliability and feasibility of the Nanoduct sweat test system compared to the gold standard tests QPIT and Macroduct.
ID
Source
Brief title
Condition
- Exocrine pancreas conditions
- Appetite and general nutritional disorders
- Congenital respiratory tract disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint: Failure rate of the Nanoduct.
Secondary outcome
Secondary endpoints: sensitivity, specificity, upper and lower cut-off points,
time to diagnosis.
Background summary
A high chloride concentration determined in sweat is the gold standard to
confirm the diagnosis Cystic Fibrosis (CF). Validated methods for performing a
sweat test are the Quantative Pilocarpine Iontophoresis (QPIT) method and the
Macroduct. In young infants, for example neonates with a positive newborn
screening test for CF, the sweat test often fails. This may lead to a
diagnostic delay and a long stressful period for the parents. The Nanoduct is a
new system for performing a sweat test, but this method is not yet validated as
a diagnostic instrument.
Study objective
To determine the reliability and feasibility of the Nanoduct sweat test system
compared to the gold standard tests QPIT and Macroduct.
Study design
A prospective comparing study te determine the failure rate of the Nanoduct
versus the QPIT/ Macroduct.
Intervention
Nanoduct sweat test and gold standard test (QPIT or Macroduct).
Study burden and risks
All infants will have to undergo two tests instead of one. The sweat test is
not painful nor distressing. The risk for complications is practically absent,,
the only risks reported are mild burns or skin irritation when the test is
performed by non-skilled personnel or when the protocol is not followed. For
the included children there is no benefit as we will rely on the results of the
gold standard test.
Postbus 1
3720 BA Bilthoven
Nederland
Postbus 1
3720 BA Bilthoven
Nederland
Listed location countries
Age
Inclusion criteria
Newborns referred to the hospital for a sweat test after newborn screening. Children aged < 2 months with a suspected diagnosis of Cystic Fibrosis. informed consent has been obtained from the parents.
Exclusion criteria
Newborns with severe eczema or sepsis (sweat test results are not reliable). Infants with meconiumileus. Informed consent cannot be obtained.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL20953.000.08 |