preschool wheeze preschool wheeze
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Children aged 2 to 6 years with a doctor*s diagnosis of preschool wheeze - Children have an indication for regular follow-up of at least one year by a paediatrician because of respiratory symptoms; - Children are treated with inhaler medication, including inhaled corticosteroids; - A history of at least one episode of wheezing within the last 12 months, assessed by a healthcare professional, either directly observed by the professional or reported by the patient’s parents/caregivers, or: - At least one hospital admissions due to pulmonary symptoms before inclusion. - Informed consent of parents/caregivers
Exclusion criteria
Exclusion criteria: - Underlying chronic cardiopulmonary or neuromuscular condition, or known recurrent aspirations; - Underlying syndromes associated with pulmonary comorbidities; - Prematurity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint for this study is the number of symptom free days (SFD) within the last four weeks of the study (measured at T=12) as reported by parents/caregivers during the last study visit. SFDs will be based on the TRACK questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptoms scores using the TRACK questionnaire Quality of life of caregivers Perceived therapy adherence Continuous medication adherence monitoring using smartinhalers Cost-effectiveness analysis Healthcare consumption Patient reported experiences measures (PREMs) Perceived self-management | — |
Countries
Netherlands
Contacts
Radboud Universitair Medisch Centrum