A Study of Sweat Testing Using a Quantitative Patch

The primary aim of the study is to determine if the CF Quantum Sweat Test provides sweat chloride results that are equivalent to the results from traditional sweat testing. The secondary aim of the study is to assess the quantity not sufficient rate of the CF Quantum Sweat Test compared to traditional sweat testing.

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Key information

Conditions

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

Age range

2 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota, Minneapolis, Minnesota, United States

About this study

All 50 states and the District of Columbia are performing newborn screening for cystic fibrosis (CF). Infants who have a positive newborn screen require follow-up with a sweat test. Gibson-Cooke Quantitative Pilocarpine Iontophoresis (GCQPIT) requires collecting sweat in microbore tubing or on gauze/filter paper and analyzing sweat using a chloridometer. This test has many difficulties including specimens that are quantity not sufficient (QNS), many steps of pipetting solutions in the laboratory, and the need for a chloridometer to analyze sweat chloride concentration. The only manufacturer of a chloridometer has ceased production of this instrument. The CF Quantum® Sweat Test System (CFQT) overcomes all of the difficulties of GCQPIT. This pilot study will determine if the CFQT provides results that are equivalent to GCQPIT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

clinical diagnosis of cystic fibrosis
patients who require a sweat test

Exclusion criteria

Infants less than 48 hours of age
Patient is receiving oxygen by open delivery
collection site has diffuse inflammation or rash

Treatment and study plan

Primary outcomes

sweat chloride value

Time frame: once, at enrollment (baseline)

Sweat chloride measurements obtained by GCQPIT and CFQT

Secondary outcomes

QNS rate

Time frame: once, at enrollment (baseline)

QNS rate of CFQT compared to GCQPIT

Sponsors and collaborators

Lead sponsor

Polychrome Medical, Inc.

Industry

Registry information

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: May 2, 2011
Registry last updated: Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed