An innovative breath test for better care for children with asthma-like symptoms

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27561

Enrollment

220

Registered

2018-10-11

Start date

2019-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asthma, asthma-like symptoms, preschool wheezing, transient wheeze, viral wheeze

Interventions

Children will be randomised into an intervention group (n=110), in which the doctors and parents will be informed about the diagnosis, or a ‘usual care’ (control) group (n=110), in which the diagnosis

Eligibility

Inclusion criteria

Inclusion criteria: - Children aged between 2 and 4 years old. - Presence of objectified (by a physician or nurse) complaints of wheezing and shortness of breath.

Exclusion criteria

Exclusion criteria: - Recent systemic course of corticosteroids or antibiotics (< 1 month before test) - Other chronic inflammatory disease than asthma (e.g. inflammatory bowel disease, auto-immune disorders, rheumatoid arthritis) - Mental disability - Other chronic diseases (e.g. cardiac disease, congenital lung disease, kidney or liver disease) - Not able to perform the study procedures adequately.

Design outcomes

Primary

Measure	Time frame
The main outcome parameter is % of well controlled asthma-like symptoms after 1-year follow-up. The % well controlled asthma-like symptoms during the study period will be based on the validated TRACK questionnaire. This questionnaire is completed by the parents and doctors and specifically developed for use in this age group, independent of the diagnosis. A score of 80 or more is defined as well controlled disease.	—

Measure

Time frame

The main outcome parameter is % of well controlled asthma-like symptoms after 1-year follow-up. The % well controlled asthma-like symptoms during the study period will be based on the validated TRACK questionnaire. This questionnaire is completed by the parents and doctors and specifically developed for use in this age group, independent of the diagnosis. A score of 80 or more is defined as well controlled disease.

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Secondary

Measure	Time frame
Secondary outcome parameters are pharmacotherapy, growth retardation and other side-effects of medication, exacerbations/hospital admissions, quality of life, lung function, allergy, blood eosinophils, the asthma predictive index (API) index, absence of school and work, healthcare resource use and –costs (standard and extra clinical visits, hospital admissions, referrals), costs outside healthcare, cost-effectiveness, asthma diagnosis at 6 years, gene expression, immunological cells, microbiome, epigenomics, gene polymophisms.	—

Measure

Time frame

Secondary outcome parameters are pharmacotherapy, growth retardation and other side-effects of medication, exacerbations/hospital admissions, quality of life, lung function, allergy, blood eosinophils, the asthma predictive index (API) index, absence of school and work, healthcare resource use and –costs (standard and extra clinical visits, hospital admissions, referrals), costs outside healthcare, cost-effectiveness, asthma diagnosis at 6 years, gene expression, immunological cells, microbiome, epigenomics, gene polymophisms.

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Contacts

Public ContactEdward Dompeling

Research Institute CAPHRI, Dept. of Pediatric Pulmonology PO BOX 5800

edward.dompeling@mumc.nl+ 31 (0) 43-3877248

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)