Status:
NOT_YET_RECRUITING
Sweat Testing in Infants: Comparing Sweat Collection on Upper Vs Lower Limbs
Lead Sponsor:
Universitair Ziekenhuis Brussel
Collaborating Sponsors:
EliTechGroup
Conditions:
Cystic Fibrosis (CF)
Eligibility:
All Genders
10-6 years
Phase:
NA
Brief Summary
The goal of this study is to compare the rate of Quantity Not Sufficient (QNS) during sweat collection in infants under 6 months of age, using the Macroduct Advanced device for sweat testing. The main...
Detailed Description
This is a prospective, observational study aimed at evaluating the effectiveness of the Macroduct Advanced device for sweat testing in infants under 6 months of age. The primary goal is to compare the...
Eligibility Criteria
Inclusion
- minimal 3,000 kg
- after a positive newborn screening (NBS) test. During this test, newborns are screened for rare diseases including CF. In case of a positive NBS test for CF, a sweat test is routinely performed to confirm or withdraw the diagnosis.
- after clinical assessment for CF, with ST as diagnostic step
- siblings of patients with CF in order to exclude CF
- CF patients who are willing to participate
- Healthy infants, born at the maternity unit of UZ Brussel, of which parents are willing to participate
Exclusion
- chromosome abnormalities
- metabolic abnormalities
- cardiopathies
- eczema
- important skin lesions on the limbs
- use of systemic corticosteroids
- critically ill patients (for example hemodynamically unstable)
Key Trial Info
Start Date :
March 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06902363
Start Date
March 30 2025
End Date
August 1 2025
Last Update
March 30 2025
Active Locations (1)
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1
UZ Brussel
Jette, Brussels Capital, Belgium, 1090