Clinical evaluation of a new sweat test system in the diagnosis of cystic fibrosis after newborn screening

Clinical evaluation of a new sweat test system in the diagnosis of cystic fibrosis after newborn screening - The nanoduct study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32874

Enrollment

100

Registered

2009-01-22

Start date

2009-01-28

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Interventions

QPIT or Macroduct sweat test ('gold standard' test) and Nanoduct.

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Succes rate of the Nanoduct system.	—

Secondary

Measure	Time frame
Sensitivity, specificity, upper and lower cut-off values, time to diagnosis.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)