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An electronic nose in infants with respiratory wheeze.


- candidate number4634
- NTR NumberNTR1566
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-nov-2008
- Secondary IDs08/153 MEC AMC
- Public TitleAn electronic nose in infants with respiratory wheeze.
- Scientific TitleAn electronic nose in sub-phenotyping infants with respiratory disease.
- ACRONYMWheezy Infants study
- hypothesisWe hypothesize that expiratory Volatile Organic Compounds analysis by an electronic nose is capable of discriminating between asymptomatic infants and infants with respiratory wheeze.
- Healt Condition(s) or Problem(s) studiedElectronic nose, Wheezing, Volatile organic compounds (VOCs)
- Inclusion criteria1. <3 years
2. Parent-reported/ physician-reported wheeze
- Exclusion criteria1. >3 years
2. Metabolic, genetic or syndromal disorders
3. Inflammatory diseased underlying respiratory tract disease
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 3-dec-2008
- planned closingdate3-dec-2009
- Target number of participants105
- InterventionsNone; diagnostic study:
One hundred five children (< 3 years) will be included: 35 children with confirmed wheeze, 35 children with parent-reported wheeze (not confirmed by a physician) and 35 healthy controls. Two exhaled breath samples of each child will be analysed by means of discriminant analysis on principal component reduction.
- Primary outcomeDiscriminating between various clinically difined subgroups of patients in a so-called trainingset.
Identification of newly recruited subjects from the same subgroups in a so-called validation set.
- Secondary outcomenone
- Timepoints- measurements take place in a single visit.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESM.D. Niki Fens
- CONTACT for SCIENTIFIC QUERIESM.D. Niki Fens
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Asthma Foundation
- PublicationsN/A
- Brief summaryRationale:
Population studies have shown that 1 in 3 children have more than one episode of parent-reported wheezing before the age of 3 years. Especially the confirmation of this wheeze by a physician appears to be associated with the development of asthma and persistence of asthmatic symptoms beyond childhood. Pre-school children with confirmed wheeze appear to already exhibit the major histological features of asthma in the bronchial mucosa. Recent studies have shown that non-invasive molecular pattern recognition of volatile organic compounds (VOCs) in exhaled air is capable of discriminating between asthmatic children and controls. An electronic nose is an innovative method of analysing these VOCs real-time. Therefore, our current aim is to assess the potential of non-invasive exhaled breath profiling by electronic nose in sub-phenotyping infants with respiratory wheeze.

Hypothesis:
We hypothesize that expiratory VOC-analysis by electronic nose is capable of:
1. Discriminating between asymptomatic infants and infants with respiratory wheeze.
2. Discriminating between parent-reported and doctors-confirmed wheezy infants.

Methods and Analysis:
One hundred five children (< 3 years) will be included: 35 children with confirmed wheeze, 35 children with parent-reported wheeze (not confirmed by a physician) and 35 healthy controls. Two exhaled breath samples of each child will be analysed by means of discriminant analysis on principal component reduction.

Relevance:
- This study evaluates the potential of a non-invasive electronic nose in objectively identifying a subgroup of infants with respiratory wheeze who are at risk of developing asthma.
-The true incidence of asthma in these high-risk children will need to be established by a separate prospective follow-up study.

Sampling:
Children will breathe normally through a face-mask into a modified Babyhaler®, with reversed valve systems (see figure 1). This allows tidal inspiration of room air and tidal expiration into the Babyhaler®. During tidal breathing the eNose will continuously sample air through a tube connected to the modified Babyhaler®
- Main changes (audit trail)
- RECORD28-nov-2008 - 10-okt-2009


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