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

NCT06902363 | Not Yet Recruiting

• 1 other identifier: 24147_Zweetteststudi
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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?

Conditions

Cystic Fibrosis (CF)

Keywords

Cystic fibrosis; Sweat testing; Sweat test; Infants; Quantity non sufficient

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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.

Study Arms (1)

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.

Device: Macroduct Advanced

Interventions

Macroduct Advanced DEVICE

Sweat stimulation and collection using the Macroduct Advanced system on two anatomical sites (forearm and thigh) in infants under 6 months of age.

Comparison of Sweat Collection Sites: Forearm vs. Thigh

Eligibility Criteria

• Age: 10 Days - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• chromosome abnormalities
• metabolic abnormalities
• cardiopathies
• eczema
• important skin lesions on the limbs
• use of systemic corticosteroids
• critically ill patients (for example hemodynamically unstable)

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• EliTechGroup: collaborator

Study Sites (1)

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

Location

Related Publications (6)

• 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.

  PMID: 32797669 BACKGROUND

• Taylor 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.

  PMID: 23849497 BACKGROUND

• Vermeulen 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.

  PMID: 28017620 BACKGROUND

• Massie 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.

  PMID: 29332976 BACKGROUND

• LeGrys VA, Briscoe D, McColley SA. Sweat testing: specimen collection and quantitative chloride analysis. CLSI Guideline 2019;C34

  BACKGROUND

• 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.

  PMID: 35063396 BACKGROUND

Related Links

• Classification of people based on ethnicity

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Elke De Wachter, Prof. Dr.

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jarne De Maeyer, Bachelor of Sc in Medicine

CONTACT

+32476782165; jarne.de.maeyer@vub.be

Elke De Wachter, Prof. Dr.

CONTACT

elke.dewachter@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: March 30, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)