chronic respiratory disease lungdisease
Conditions
Interventions
In this study a lungfunctionmeasurement will be performed, in young children,
to diagnose possible asthma. In advance to measurement of FEV1 and FVC a
reversibility test with salbutamol will be perf
Sponsors
Universiteit Maastricht
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: Only those children will be invited who have participated in the first part (the period before birth untill the age of two) of the study. In the first part the main inclusion criterium was: a negative family history of asthma (i.e. no biological father, mother, brothers and/or sisters with asthma).
Exclusion criteria
Exclusion criteria: In the first part of the study, the exclusion criteria were 'spontaneous abortion, miscarriage, language problems, serious health problems in the child at birth for which hospitalization is necessary. In this second part there will be no exta exclusion criteria, except that when children are not able to undergo a lungfunction measurement because of serious (co-) morbidity, the will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study parameters The main *cost* parameters are the direct-, indirect and intervention costs. The main primary effectiveness study parameter will be a diagnosis of asthma according to the international GINA guidelines. For the children from the RAKKER2 study this will be the same as for the children from the PREVASC study and will be based on an algorithm that is composed of the results of the ISAAC questionnaire, GP registration and lung function measurements, as well as total and specific immunoglobulin E (IgE) levels. A child will be labelled with *certain asthma* whenever lung function is deviating from the norm$ accompanied by at least one of the following items (ISAAC questionnaire or GP registration): *ISAAC questionnaire: • Has your child had any wheezing in the chest from its 5th to its 6th birthday? Answer: Yes. • How many attacks of wheezing did your child experience during this period? Answer: >= 1. • How often did your child wake up by wheezing in the chest? Answer: >= 1/week. • Has your child had any chest tightness from its 5th to its 6th birthday? Answer: Yes. • How many attacks of chest tightness did your child experience during this period? Answer: >=1. • How often did your child wake up with chest tightness during this period? Answer: >= 1 night/week. • How often did your child wake up with coughing, without having a cold or breast infection? Answer: >= 1 night/week. *GP registration: Expiratory wheezing at least registered once. • Wheezing without exercise, at least registered once. • Nightly cough more than once registered. • Shortness of breath without exercise at least registered once. $Lung function is deviating from the norm: FEV1/FVC (ml) = 9% and/or PC20 | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life is a secundary parameter in this study | — |
Countries
Netherlands
Outcome results
None listed