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

NCT ID: NCT03377686

Last Updated: 2017-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asthma Cystic Fibrosis

Keywords

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paediatrics breath analysis volatile organic compounds respiratory diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Asthma

Inflammation markers in exhaled breath will be used in 20 children aged 6 to 16 years with doctor's diagnosed asthma

inflammation markers in exhaled breath

Intervention Type DIAGNOSTIC_TEST

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

inflammation markers in exhaled breath

Intervention Type DIAGNOSTIC_TEST

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

inflammation markers in exhaled breath

Intervention Type DIAGNOSTIC_TEST

non-invasive, cross-sectional, assessment of inflammation markers in exhaled breath with various techniques (observational)

Interventions

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inflammation markers in exhaled breath

non-invasive, cross-sectional, assessment of inflammation markers in exhaled breath with various techniques (observational)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Children aged 6 to 16 years

Exclusion Criteria

* Asthma group: Doctor's diagnosed asthma
* Cystic Fibrosis group: A diagnosis of cystic fibrosis, confirmed by a sweat test or genetic analysis


* 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
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edward Dompeling, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Centre

Locations

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Maastricht University Medical Centre

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

References

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Bannier MAGE, van de Kant KDG, Jobsis Q, Dompeling E. Feasibility and diagnostic accuracy of an electronic nose in children with asthma and cystic fibrosis. J Breath Res. 2019 May 8;13(3):036009. doi: 10.1088/1752-7163/aae158.

Reference Type DERIVED
PMID: 30213921 (View on PubMed)

Other Identifiers

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NL 53995.068.15

Identifier Type: -

Identifier Source: org_study_id