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The Nanoduct study: a new sweat test system tested

The Nanoduct study: a new sweat test system tested - The Nanoduct study

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON31574
Enrollment
330
Registered
2008-06-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

Cystic Fibrosis mucoviscoidosis

Interventions

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

Sponsors

RIVM
Lead Sponsor

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

Exclusion criteria

Exclusion criteria: Newborns with severe eczema or sepsis (sweat test results are not reliable). Infants with meconiumileus. Informed consent cannot be obtained.

Design outcomes

Primary

MeasureTime frame
Primary endpoint: Failure rate of the Nanoduct.

Secondary

MeasureTime frame
Secondary endpoints: sensitivity, specificity, upper and lower cut-off points, time to diagnosis.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)