Sweat Testing in Infants: Comparing Sweat Collection on Upper Vs Lower Limbs (NCT06902363) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Sweat Testing in Infants: Comparing Sweat Collection on Upper Vs Lower Limbs
Belgium20 participantsStarted 2025-03-30
Plain-language 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 question it aims to answer is:
Does sweat collection from the thigh (lower limb) reduce the QNS rate compared to the forearm (upper limb) in infants? Do chloride concentration levels differ between sweat collected from the forearm and thigh in the same infants?
Who can participate
Age range
10 Days – 6 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* chromosome abnormalities
* metabolic abnormalities
* cardiopathies
* eczema
* important skin lesions on the limbs
* use of systemic corticosteroids
* critically ill patients (for example hemodynamically unstable)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of Sweat Collection Sites: Forearm vs. Thigh in Infants (Primary Outcome: QNS Rate)
Timeframe: Measurement of QNS rate will be taken at the time of sweat collection from both forearm and thigh, during each testing session. Data will be recorded in real-time, and analysis will occur immediately following the collection.