No registrations found.
ID
Source
Brief title
Health condition
preschool wheezing, asthma
Sponsors and support
Intervention
Outcome measures
Primary outcome
The predictive value of the phenotypes episodic viral wheeze and multiple trigger wheeze (clinical as well as diary-based) in the development of asthma
Secondary outcome
The occurrence of viral upper respiratory infections at preschool age and the risk of developing asthma, and differences in microbiome at preschool age between children who develop childhood asthma and children who do not.
Background summary
Rationale: Recurrent wheezing is a common symptom in preschool children. The clinical wheezing phenotypes episodic viral wheeze (EVW) and multiple trigger wheeze (MTW) were proposed in 2008 by an ERS task force to serve as a basis for prognosis and therapeutic decisions. The original WHEEP study showed EVW and MTW to be variable over time within patients. Moreover, paediatrician-assessed classification of these phenotypes based on clinical history do not correspond to phenotypes based on prospectively recorded symptoms.
Objective: We aim to investigate the predictive value of the preschool wheeze phenotypes EVW, MTW and viral upper respiratory infections in the development of childhood asthma.
Study design: A prospective multicentre cohort study.
Study population: 6- to 9-year old children who were known for recurrent wheezing at the age of 1- to 4- years, treated by hospital-based paediatricians and included in our previous study. Recurrent wheezing was defined as a minimum of 3 reported episodes in the year before inclusion, of which at least one must have been confirmed by a paediatrician.
Main study parameters/endpoints: Primary outcome measures are the predictive value of EVW and MTW (clinical as well as diary-based) in the development of asthma later in life.
Secondary outcome measures are the occurrence of viral upper respiratory infections at preschool age and the risk of developing asthma, and differences in microbiome at preschool age between children who develop childhood asthma and children who do not.
Also, the sensitivity and specificity of known asthma predictive scores will be determined in our cohort: the Asthma Predictive Index (API) and the Prevention and Incidence of Asthma and Mite Allergy risk score (PIAMA).
Nature and extent of the burden and risks associated with participation: Parents and children will have to visit the outpatient clinic once. During this visit, a pulmonary function test will be performed, a throat swab will be collected and venapunction for blood tests on eosinophilia, total IgE and RAST test for inhaled allergens will take place. The ISAAC (International Study of Asthma and Allergies in Childhood) standardized questionnaire on asthma will be completed. The risks associated with participation can be considered negligible and the burden minimal.
Study objective
The development of childhood asthma can be predicted by the wheeze phenotype at preschool age
Study design
MEC approval 25-04-19
Intervention
questionnaires, lung function tests, throat swab
Inclusion criteria
6- to 9-year old children who were known for recurrent wheezing at the age of 1- to 4- years, treated by hospital-based pediatricians and included in our previous (WHEEP)study. Recurrent wheezing was defined as a minimum of 3 reported episodes in the year before inclusion, of which at least one must have been confirmed by a pediatrician.Children were then recruited from pediatric departments of ten general and academic hospitals in the Netherlands. During the 1-year (WHEEP)study period wheeze patterns were classified from patient diaries and compared to pediatrician assigned phenotypes
Exclusion criteria
No new exclusion criteria. As in the former (WHEEP)study, children of whom their parents do not understand the Dutch language are not eligible.
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL7692 |
| Other | MEC-U : R18-052 |