Reversibility of Bronchial Obstruction in Children Born Preterm

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).

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Key information

Conditions

Bronchopulmonary Dysplasia Bronchial Diseases Bronchial Hyperreactivity Bronchial Obstruction Chronic Lung Disease of Newborn Chronic Lung Disease of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Preterm Birth Complication Respiratory Tract Diseases Reversible Dilatation Ventilator-Induced Lung Injury

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First faculty of Medicine, Charles university.

Prague, 128 00, Czechia

About this study

Outpatient follow-up - Parents are asked to sign the study consent form if the child meets the indication criteria. If the trial subject is not taking inhaled therapy, he/she may immediately continue to Check-up A. If the subject is taking short- or long-acting bronchodilators, these medications must be discontinued before each check-up and at the following intervals:

Short-acting β2 agonists (SABA) - 12 hours before the examination
Short-acting inhaled cholinergic antagonists (e.g. ipratropium bromide) - 12 hours before the examination
Long-acting inhaled betamimetics (long-acting β2 agonists, LABAs) - 48 hours before the examination
Long-acting muscarinic antagonists (LAMA) - one week before the examination
Check-up A - Baseline pre-interventional spirometry may be performed if the subject has no evidence of acute respiratory infection or has not had an acute respiratory infection two weeks previously. Otherwise, the examination should be rescheduled. Before baseline spirometry, the child is randomized to a dilatation test with inhaled salbutamol, ipratropium, or a combination of fenoterol/ipratropium. After a defined time interval (15 - 30 minutes), post-interventional spirometry follows.

The subject is invited to attend Check-up B (which preferably follows 1 to 30 days after Check-up A, but no later than 3 months).

Check-up B - Baseline pre-interventional spirometry may be performed if the subject has no evidence of acute respiratory infection or has not had an acute respiratory infection two weeks previously. Otherwise, Check-up B should be rescheduled. Before baseline spirometry, another inhaled bronchodilator according to the preceding randomisation is applied. After a defined time interval (15 - 30 minutes), post-interventional spirometry follows. Resting spirometry with a dilatation test with another drug, the choice of which is guided by randomization, is performed.
Check-up C - Baseline pre-interventional spirometry may be performed if the subject has no evidence of acute respiratory infection or has not had an acute respiratory infection two weeks previously. Otherwise, Check-up C should be rescheduled. Baseline spirometry with the last bronchodilator not yet used is performed.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

Change of spirometric parameters of bronchial obstruction in children born preterm to inhaled salbutamol, ipratropium bromide and combination of fenoterol with ipratropium bromide

Time frame: baseline and post-interventional spirometry after 15-30 minutes (interval specific to bronchodilator) during three check-ups with min. time interval between check-ups 24 hours and max. 30 days

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

Time frame: baseline and post-interventional spirometry after 15-30 minutes (interval specific to bronchodilator) during three check-ups with min. time interval between check-ups 24 hours and max. 30 days

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

Time frame: baseline and post-interventional spirometry after 15-30 minutes (interval specific to bronchodilator) during three check-ups with min. time interval between check-ups 24 hours and max. 30 days

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.

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study title

Bronchodilator Response To Inhaled Beta-2 Agonist and Anticholinergic Drugs in Children Born Preterm

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Oct 31, 2023
Registry last updated: Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed