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.The aim of…
ID
Source
Brief title
Condition
- Allergic conditions
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of the study will be:
- the discrimination between the various clinically defined subgroups of
patients in a so-called *training-set.*
- the identification of newly recruited subjects from the same subgroups in a
so-called *validation-set*.
Secondary outcome
not-applicable
Background summary
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.
Study objective
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.
The aim of this study is to address this hypothesis by integrating the clinical
profiles and exhaled smell prints in infants with wheeze in a case-control,
cross-sectional study.
Study design
The study has a case-control, cross-sectional design comparing infants with
confirmed wheeze, with parent-reported wheeze and age-matched healthy children.
The study consists of two phases:
Phase1: Trainingset: All children with parent-reported wheeze will be seen. The
wheezing will be assessed by a qualified lung-physician and the exhaled air
will be analyzed by the electronic nose. Additionally a group of healthy
children will be included.
Phase2: Validation set: The sensitivity, specificity, negative and positive
predictive value of the classification algorithms developed on basis of these
children will be examined by detecting and monitoring disease in prospectively
enrolled subjects on basis of an intention to diagnose.
Study burden and risks
The collection of expiratory air is totally non-invasive and thus without any
health risk. This was comfirmed by pilot studies.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients:
Informed consent obtained from parents
age between 0 and 2 years;Healthy controls:
Informed consent obtained from parents
age between 0 and 2 years
Exclusion criteria
Patients:
Present metabolic or syndrom disorder
Underlying respiratory tract disease, like congenital airway abnormalities, cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia or bronchiectasis;Healthy controls:
Present metabolic or syndrome disorder
Respiratory tract disease
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL23623.018.08 |