Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Breath Analysis in Children by New Point-of-care Instruments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03377686
Recruitment Status : Completed
First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:
In this study new hand-held devices for measuring exhaled breath will be tested in children with asthma, CF, and healthy controls. Main objectives will be feasibility and discriminative value of these techniques.

Condition or disease Intervention/treatment
Asthma Cystic Fibrosis Diagnostic Test: inflammation markers in exhaled breath

Detailed Description:

Rationale: Assessment of volatile organic compounds (VOCs) is a new recently developed non-invasive technique to assess airway inflammation. The non-invasive character makes it highly suitable for use in (preschool) children. However, the analysis of VOCs by gas chromatography mass spectrometry technique (GC-MS), the gold standard, is expensive and time consuming. Therefore, new hand-held devices (such as electronic Noses (eNoses) and Ion Mobility Spectrometer techniques) have been developed. However, these new point-of-care instruments have not been studied in children.

Objectives: 1) To test whether new point-of-care instruments for the measurement of VOCs in exhaled breath are feasible for use in children aged 6 to 16 years; 2) To explore whether these techniques can differentiate between healthy children, asthmatic children and children with Cystic Fibrosis (CF).

Study design: Cross-sectional study design. Several VOCs tests will be performed in all participants.Besides, fraction of exhaled nitric oxide (FeNO) and inflammatory markers in exhaled breath condensate (EBC) will be measured.

Study population: Three groups of children aged 6 to 16 years: 20 healthy children, 20 children with doctor's diagnosed asthma, 20 children with CF.

Main study parameters/endpoints: Each technique will be evaluated for its use and feasibility in children. For each technique, VOC profiles between study groups will be evaluated for its discriminative power.

Layout table for study information
Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Feasibility and Diagnostic Value of New Point-of-care Instruments for Breath Analysis in Children With Asthma, Cystic Fibrosis (CF), and Healthy Controls
Actual Study Start Date : March 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Asthma
Inflammation markers in exhaled breath will be used in 20 children aged 6 to 16 years with doctor's diagnosed asthma
Diagnostic Test: inflammation markers in exhaled breath
non-invasive, cross-sectional, assessment of inflammation markers in exhaled breath with various techniques (observational)

Cystic fibrosis
Inflammation markers in exhaled breath will be used in 20 children aged 6 to 16 years with CF
Diagnostic Test: inflammation markers in exhaled breath
non-invasive, cross-sectional, assessment of inflammation markers in exhaled breath with various techniques (observational)

Healthy
Inflammation markers in exhaled breath will be used in 20 children aged 6 to 16 years old without respiratory diseases
Diagnostic Test: inflammation markers in exhaled breath
non-invasive, cross-sectional, assessment of inflammation markers in exhaled breath with various techniques (observational)




Primary Outcome Measures :
  1. Number of participants with adverse events directly related to the various point-of-care tests used [ Time Frame: Questionnaire will be done directly after specific test (1 day). No long term (S)AE is expected and measurement of each test is only performed once. ]
    Any adverse event of any kind will be noted. Furthermore, each participant will be asked whether the test was easy to perform. This question can be answered on a 5-point scale (0=totally agree that test was easy to perform, 4= totally disagree that test was easy to perform)


Secondary Outcome Measures :
  1. Sensitivity and Specificity of new point-of-care Aeonose eNose in diagnosing asthma. [ Time Frame: Measurements will be analysed within 6 to 12 months ]
    Aeonose eNose measurements will be analysed by in house software program (Aethena) developed by eNose company (Zutphen, Netherlands). To test sensitivity and specificity, first an area under the receiver operating curve must be calculated with the aforementioned software program. Hereafter sensitivity and specificity of the eNose can be calculated.

  2. Sensitivity and Specificity of new point-of-care Aeonose eNose in diagnosing cystic fibrosis. [ Time Frame: Measurements will be analysed within 6 to 12 months ]
    Aeonose eNose measurements will be analysed by in house software program (Aethena) developed by eNose company (Zutphen, Netherlands). To test sensitivity and specificity, first an area under the receiver operating curve must be calculated with the aforementioned software program. Hereafter sensitivity and specificity of the eNose can be calculated.

  3. Sensitivity and Specificity of Ion Mobility Spectrometry in diagnosing asthma. [ Time Frame: Measurements will be analysed within 6 to 12 months ]
    IMS measurements will be analysed by software program developed for using IMS data (Visual Now, Ganshorn, Dortmund, Germany). By IMS different VOCs peaks are generated. By using the aforementioned software, these peaks can be analysed and sensitivity and specificity between asthma and healthy children can be calculated.

  4. Sensitivity and Specificity of Ion Mobility Spectrometry in diagnosing cystic fibrosis. [ Time Frame: Measurements will be analysed within 6 to 12 months ]
    IMS measurements will be analysed by software program developed for using IMS data (Visual Now, Ganshorn, Dortmund, Germany). By IMS different VOCs peaks are generated. By using the aforementioned software, these peaks can be analysed and sensitivity and specificity between CF and healthy children can be calculated.


Biospecimen Retention:   Samples Without DNA
inflammation markers in exhaled breath


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Three groups of children aged 6 to 16 years: 20 healthy children, 20 children with doctor's diagnosed asthma, 20 children with CF.
Criteria

Inclusion Criteria:

  • Children aged 6 to 16 years
  • Healthy group: See exclusion criteria
  • Asthma group: Doctor's diagnosed asthma
  • Cystic Fibrosis group: A diagnosis of cystic fibrosis, confirmed by a sweat test or genetic analysis

Exclusion criteria

  • Recent course of prednisone or antibiotics (< 1 month before test)
  • Passive smoking
  • Other chronic inflammatory disease (e.g. inflammatory bowel disease, rheumatic disease, auto-immune disease)
  • Healthy children:

    • No current or history of respiratory symptoms
    • No current or history of allergic rhinitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377686


Locations
Layout table for location information
Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Edward Dompeling, MD, PhD Maastricht University Medical Centre
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03377686    
Other Study ID Numbers: NL 53995.068.15
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht University Medical Center:
paediatrics
breath analysis
volatile organic compounds
respiratory diseases
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Asthma
Fibrosis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases