This observational study aims to compare responses to different, commonly used inhaled bronchodilators in children born preterm with bronchial obstruction at spirometry. All children were diagnosed with Chronic Lung Disease of Immaturity (CLDI).
The main questions are:
* Is any inhaled bronchodilator or their combination generally superior in children with CLDI when assessing the reversibility of bronchial obstruction? * Is there an individual difference in the effect of betamimetic, anticholinergic or their combination between children with CLDI?
Participants will:
* Come to our clinic in a stable state without acute infection and they will be randomly assigned to the first inhaled bronchodilator. * They will then perform a spirometry test before and after the inhalation of the drug. * This visit will repeat 3 times, each with a different bronchodilator (beta2agonist, anticholinergic and their combination).
children born preterm /before the 35th week of gestational age (35+0)/
all subjects must have chronic lung disease of prematurity with bronchial obstruction, confirmed by spirometry
subjects must be able to cooperate well in spirometry
The presence of another chronic respiratory disease (e.g., cystic fibrosis, primary ciliary dyskinesia, etc.). Asthma bronchiale is not an exclusion criterion, but subjects with CLDI combined with asthma bronchiale represent a specific subgroup of subjects and we perform a standardized therapeutic test with inhaled corticosteroids (ICS) administered for at least 12 weeks via a pressurized aerosol dispenser (pMDI) via an inhaler attachment before enrollement.
Insufficient cooperation during spirometry.
children born preterm before 35+0 of gestational age (35+0) with chronic lung disease of prematurity with bronchial obstruction, confirmed by spirometry.
Cohort
Prospective
Not listed
Change of spirometric parameters of bronchial obstruction in children born preterm to inhaled salbutamol, ipratropium bromide and combination of fenoterol with ipratropium bromide
Spirometric parameters of bronchial obstruction before and after inhaled application of bronchodilator during check-up. Three types of bronchodilators (salbutamol, ipratropium bromide and combined inhaler of fenoterol with ipratropium bromide) at three different check-ups will be tested with the order selected by randomisation. Z-score of baseline (pre-interventional) spirometric expiratory flow parameters (MMEF (l/s), MEF75 (l/s), MEF50 (l/s), MEF25 (l/s) retrieved from flow-volume curve compared to post-interventional z- scores of MMEF (l/s), MEF75 (l/s), MEF50 (l/s), MEF25 (l/s) values measured after a predefined time interval specific to bronchodilator (15-30 minutes). Four standardised doses of bronchodilators will be administered with metered-dose inhaler by spacer without a mask.
Change of spirometric parameters of lung volume in children born preterm to inhaled salbutamol, ipratropium bromide and combination of fenoterol with ipratropium bromide
Spirometric parameters of lung volume before and after inhaled application of bronchodilator during check-up. Three types of bronchodilators (salbutamol, ipratropium bromide and combined inhaler of fenoterol with ipratropium bromide) at three different check-ups will be tested with the order selected by randomisation. Z-score of baseline (pre-interventional) spirometric volume parameters FEV 0.5 (ml), FVC (ml) retrieved from flow-volume curve compared to post-interventional z- scores of FEV 0.5 (l), FVC (l) values measured after a predefined time interval specific to bronchodilator (15-30 minutes). Four standardised doses of bronchodilators will be administered with metered-dose inhaler by spacer without a mask.
Change of area under the flow-volume spirometric curve in children born preterm to inhaled salbutamol, ipratropium bromide and combination of fenoterol with ipratropium bromide
Complex spirometric parameter of area under the curve before and after inhaled application of bronchodilator during check-up. Three types of bronchodilators (salbutamol, ipratropium bromide and combined inhaler of fenoterol with ipratropium bromide) at three different check-ups will be tested with the order selected by randomisation. Z-score of baseline (pre-interventional) Aex (l\*l/s) retrieved from flow-volume curve compared to post-interventional z- scores of Aex (l\*l/s) values measured after a predefined time interval specific to bronchodilator (15-30 minutes). Four standardised doses of bronchodilators will be administered with metered-dose inhaler by spacer without a mask.
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