RecruitingNCT06110481

Reversibility of Bronchial Obstruction in Children Born Preterm

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

Sponsor

Charles University, Czech Republic

Enrollment

80 participants

Start Date

Apr 1, 2021

Study Type

OBSERVATIONAL

Conditions

Chronic lung disease of prematurity Bronchopulmonary Dysplasia Chronic Lung Disease of Newborn Preterm Birth Complication Bronchial Hyperreactivity Bronchial Obstruction Reversible Dilatation

Summary

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).

Eligibility

Min Age: 5 YearsMax Age: 18 Years

Inclusion Criteria3

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 Criteria2

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.

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