A Study of Sweat Testing Using a Quantitative Patch

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01345617

Enrollment

170

Registered

2011-05-02

Start date

2012-01-31

Completion date

2013-10-31

Last updated

2018-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Days to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
sweat chloride value	once, at enrollment (baseline)	Sweat chloride measurements obtained by GCQPIT and CFQT

Secondary

Measure	Time frame	Description
QNS rate	once, at enrollment (baseline)	QNS rate of CFQT compared to GCQPIT

Countries

United States

Outcome results