Cystic Fibrosis (CF)NCT06902363
Sweat Testing in Infants: Comparing Sweat Collection on Upper Vs Lower Limbs
A study testing Macroduct Advanced in people with Cystic Fibrosis (CF), run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 days to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis (CF)
- What is being tested?
- Macroduct Advanced
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Mar 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 days to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- chromosome abnormalities
- metabolic abnormalities
- cardiopathies
- eczema
- important skin lesions on the limbs
- use of systemic corticosteroids
- critically ill patients (for example hemodynamically unstable)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elke De Wachter, Prof. Dr. contact
Belgium1 site
UZ Brussel
Jette, Brussels Capital, 1090
Elke De Wachter, Prof. Dr., +3224776061, elke.dewachter@uzbrussel.be
About this study
Official title: Sweat Testing in Infants: a Comparative Study Investigating the Collection of Sweat on the Upper Limbs Compared to the Lower Limbs
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?
Read the 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 rate of Quantity Not Sufficient (QNS) between two sweat collection sites: the forearm (upper limb) and the thigh (lower limb). The study seeks to determine whether using the thigh as an alternative collection site can reduce the incidence of QNS, a common challenge in sweat testing in infants, where at least 15 microliters of sweat are required for an accurate result.
Study Objectives:
To assess if sweat collection from the thigh results in a lower QNS rate compared to the forearm in infants.
To compare the chloride concentration levels of sweat collected from both the forearm and thigh, in order to evaluate if the collection site affects the chloride measurements.
Study Design:
Participants will undergo sweat collection from both the forearm and thigh, within the same study session, using the Macroduct Advanced device.
The QNS rate will be recorded for each collection site. Chloride levels from the sweat samples will be measured for comparison between the two sites.
The study will involve healthy infants under 6 months of age, and data will be collected to evaluate the feasibility and effectiveness of using the thigh as a collection site for sweat testing.
Primary and Secondary Outcomes:
Primary Outcome: Reduction in the QNS rate when sweat is collected from the thigh compared to the forearm.
Secondary Outcome: Comparison of chloride concentration levels from the forearm and thigh to determine if there is a significant difference in chloride levels depending on the collection site.
This study will provide valuable insights into improving the accuracy and feasibility of sweat testing in infants, especially in cases where QNS is common and may require repeated tests. If successful, using the thigh as a collection site could enhance the overall success rate of sweat tests and reduce the need for retesting, improving clinical care for infants with conditions such as cystic fibrosis.
- Conditions
- Cystic Fibrosis (CF)
- Being tested
- Macroduct Advanced
- Keywords
- Cystic fibrosis, Sweat testing, Sweat test, Infants, Quantity non sufficient
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macroduct AdvancedDevice
Sweat stimulation and collection using the Macroduct Advanced system on two anatomical sites (forearm and thigh) in infants under 6 months of age.
| Study group | Role | What they receive |
|---|---|---|
| Comparison of Sweat Collection Sites: Forearm vs. Thigh | Experimental | All enrolled infants undergo sweat testing using the Macroduct Advanced device, with simultaneous collection on the forearm (standard site) and thigh (alternative site). The goal is to compare sweat volume and chloride concentration between both anatomical sites, focusing on the rate of quantity not sufficient (QNS) outcomes. Receives: Device: Macroduct Advanced |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Sweat Collection Sites: Forearm vs. Thigh in Infants (Primary Outcome: QNS Rate)
The primary objective of this study is to compare the rate of Quantity Not Sufficient (QNS) between sweat collected from the forearm (upper limb) and the thigh (lower limb) in infants under 6 months of age. Both sites will be tested on the same infant at the same time using the Macroduct Advanced device. The goal is to determine whether sweat collection from the thigh reduces the incidence of QNS compared to the forearm, which is the traditional site for sweat testing in infants. Additionally, the study aims to assess if the circumferential size of the upper and lower limbs influences the rate of QNS.
Measured: 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.
Secondary outcomes (1)
Comparison of Chloride Concentration between Forearm and Thigh Sweat Collection in Infants
The secondary objective of this study is to compare chloride concentration values between sweat collected from the forearm (upper limb) and the thigh (lower limb) in the same infant under 6 months of age. Sweat will be collected simultaneously from both sites using the Macroduct Advanced device. This comparison aims to determine if there is a significant difference in chloride levels between the two sites, and whether the anatomical site of sweat collection impacts the chloride concentration in the samples.
Measured: Chloride concentration will be measured immediately after sweat collection from both forearm and thigh during each session, with results recorded and analyzed following each collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start30 Mar 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis (CF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- EliTechGroup
- Responsible party
- Sponsor
- Investigators
- Elke De Wachter, Prof. Dr., Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902363
- Sponsor's protocol ID
- 24147_Zweetteststudi
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McColley SA, Elbert A, Wu R, Ren CL, Sontag MK, LeGrys VA. Quantity not sufficient rates and delays in sweat testing in US infants with cystic fibrosis. Pediatr Pulmonol. 2020 Nov;55(11):3053-3056. doi: 10.1002/ppul.25027. Epub 2020 Aug 25.
PubMed 32797669Taylor NA, Machado-Moreira CA. Regional variations in transepidermal water loss, eccrine sweat gland density, sweat secretion rates and electrolyte composition in resting and exercising humans. Extrem Physiol Med. 2013 Feb 1;2(1):4. doi: 10.1186/2046-7648-2-4.
PubMed 23849497Vermeulen F, Lebecque P, De Boeck K, Leal T. Biological variability of the sweat chloride in diagnostic sweat tests: A retrospective analysis. J Cyst Fibros. 2017 Jan;16(1):30-35. doi: 10.1016/j.jcf.2016.11.008. Epub 2016 Dec 22.
PubMed 28017620Massie J, Greaves R, Metz M, Wiley V, Graham P, Shepherd S, Mackay R. Australasian Guideline (2nd Edition): an Annex to the CLSI and UK Guidelines for the Performance of the Sweat Test for the Diagnosis of Cystic Fibrosis. Clin Biochem Rev. 2017 Nov;38(3):115-130. No abstract available.
PubMed 29332976LeGrys VA, Briscoe D, McColley SA. Sweat testing: specimen collection and quantitative chloride analysis. CLSI Guideline 2019;C34
Cirilli N, Southern KW, Barben J, Vermeulen F, Munck A, Wilschanski M, Nguyen-Khoa T, Aralica M, Simmonds NJ, De Wachter E; ECFS Diagnostic Network Working Group. Standards of care guidance for sweat testing; phase two of the ECFS quality improvement programme. J Cyst Fibros. 2022 May;21(3):434-441. doi: 10.1016/j.jcf.2022.01.004. Epub 2022 Jan 19.
PubMed 35063396
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sweat Testing in Infants: a Comparative Study Investigating the Collection of Sweat on the Upper Limbs Compared to the Lower Limbs
- ClinicalTrials.gov ID
- NCT06902363
- Acronym / sponsor ID
- 24147_Zweetteststudi
- Conditions
- Cystic Fibrosis (CF)
- Keywords
- Cystic fibrosis, Sweat testing, Sweat test, Infants, Quantity non sufficient
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- EliTechGroup
- Study start
- 30 Mar 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 rate of Quantity Not Sufficient (QNS) between two sweat collection sites: the forearm (upper limb) and the thigh (lower limb). The study seeks to determine whether using the thigh as an alternative collection site can reduce the incidence of QNS, a common challenge in sweat testing in infants, where at least 15 microliters of sweat are required for an accurate result.
Study Objectives:
To assess if sweat collection from the thigh results in a lower QNS rate compared to the forearm in infants.
To compare the chloride concentration levels of sweat collected from both the forearm and thigh, in order to evaluate if the collection site affects the chloride measurements.
Study Design:
Participants will undergo sweat collection from both the forearm and thigh, within the same study session, using the Macroduct Advanced device.
The QNS rate will be recorded for each collection site. Chloride levels from the sweat samples will be measured for comparison between the two sites.
The study will involve healthy infants under 6 months of age, and data will be collected to evaluate the feasibility and effectiveness of using the thigh as a collection site for sweat testing.
Primary and Secondary Outcomes:
Primary Outcome: Reduction in the QNS rate when sweat is collected from the thigh compared to the forearm.
Secondary Outcome: Comparison of chloride concentration levels from the forearm and thigh to determine if there is a significant difference in chloride levels depending on the collection site.
This study will provide valuable insights into improving the accuracy and feasibility of sweat testing in infants, especially in cases where QNS is common and may require repeated tests. If successful, using the thigh as a collection site could enhance the overall success rate of sweat tests and reduce the need for retesting, improving clinical care for infants with conditions such as cystic fibrosis.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comparison of Sweat Collection Sites: Forearm vs. Thigh | Experimental | Device: Macroduct AdvancedAll enrolled infants undergo sweat testing using the Macroduct Advanced device, with simultaneous collection on the forearm (standard site) and thigh (alternative site). The goal is to compare sweat volume and chloride concentration between both anatomical sites, focusing on the rate of quantity not sufficient (QNS) outcomes. |
Who may qualify
- Ages
- 10 days to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- chromosome abnormalities
- metabolic abnormalities
- cardiopathies
- eczema
- important skin lesions on the limbs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Macroduct AdvancedSweat stimulation and collection using the Macroduct Advanced system on two anatomical sites (forearm and thigh) in infants under 6 months of age. | Device | Comparison of Sweat Collection Sites: Forearm vs. Thigh |
Primary outcome
Comparison of Sweat Collection Sites: Forearm vs. Thigh in Infants (Primary Outcome: QNS Rate)
Time frame: 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.
The primary objective of this study is to compare the rate of Quantity Not Sufficient (QNS) between sweat collected from the forearm (upper limb) and the thigh (lower limb) in infants under 6 months of age. Both sites will be tested on the same infant at the same time using the Macroduct Advanced device. The goal is to determine whether sweat collection from the thigh reduces the incidence of QNS compared to the forearm, which is the traditional site for sweat testing in infants. Additionally, the study aims to assess if the circumferential size of the upper and lower limbs influences the rate of QNS.
1 secondary outcome
Comparison of Chloride Concentration between Forearm and Thigh Sweat Collection in Infants
Time frame: Chloride concentration will be measured immediately after sweat collection from both forearm and thigh during each session, with results recorded and analyzed following each collection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Background: PubMed 32797669McColley SA, Elbert A, Wu R, Ren CL, Sontag MK, LeGrys VA. Quantity not sufficient rates and delays in sweat testing in US infants with cystic fibrosis. Pediatr Pulmonol. 2020 Nov;55(11):3053-3056. doi: 10.1002/ppul.25027. Epub 2020 Aug 25.
- Background: PubMed 23849497Taylor NA, Machado-Moreira CA. Regional variations in transepidermal water loss, eccrine sweat gland density, sweat secretion rates and electrolyte composition in resting and exercising humans. Extrem Physiol Med. 2013 Feb 1;2(1):4. doi: 10.1186/2046-7648-2-4.
- Background: PubMed 28017620Vermeulen F, Lebecque P, De Boeck K, Leal T. Biological variability of the sweat chloride in diagnostic sweat tests: A retrospective analysis. J Cyst Fibros. 2017 Jan;16(1):30-35. doi: 10.1016/j.jcf.2016.11.008. Epub 2016 Dec 22.
- Background: PubMed 29332976Massie J, Greaves R, Metz M, Wiley V, Graham P, Shepherd S, Mackay R. Australasian Guideline (2nd Edition): an Annex to the CLSI and UK Guidelines for the Performance of the Sweat Test for the Diagnosis of Cystic Fibrosis. Clin Biochem Rev. 2017 Nov;38(3):115-130. No abstract available.
- BackgroundLeGrys VA, Briscoe D, McColley SA. Sweat testing: specimen collection and quantitative chloride analysis. CLSI Guideline 2019;C34
- Background: PubMed 35063396Cirilli N, Southern KW, Barben J, Vermeulen F, Munck A, Wilschanski M, Nguyen-Khoa T, Aralica M, Simmonds NJ, De Wachter E; ECFS Diagnostic Network Working Group. Standards of care guidance for sweat testing; phase two of the ECFS quality improvement programme. J Cyst Fibros. 2022 May;21(3):434-441. doi: 10.1016/j.jcf.2022.01.004. Epub 2022 Jan 19.
- Classification of people based on ethnicityLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elke De Wachter, Prof. Dr. contact
Elke De Wachter, Prof. Dr. principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macroduct Advanced in people with Cystic Fibrosis (CF), run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jarne De Maeyer, Bachelor of Sc in Medicine (+32476782165, jarne.de.maeyer@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Sweat Collection Sites: Forearm vs. Thigh in Infants (Primary Outcome: QNS Rate) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06902363, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.