Sweat Testing in Infants: Comparing Sweat Collection on Upper Vs Lower Limbs

March 24, 2025 updated by: Universitair Ziekenhuis Brussel

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Comparison of Sweat Collection Sites: Forearm vs. Thigh
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.
Device: Macroduct Advanced
Sweat stimulation and collection using the Macroduct Advanced system on two anatomical sites (forearm and thigh) in infants under 6 months of age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Collaborators

EliTechGroup

Investigators

  • Principal Investigator: Elke De Wachter, Prof. Dr., Universitair Ziekenhuis Brussel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2025

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

March 24, 2025

First Submitted That Met QC Criteria

March 24, 2025

First Posted (Actual)

March 30, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24147_Zweetteststudi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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