Actively Recruiting
Reversibility of Bronchial Obstruction in Children Born Preterm
Led by Charles University, Czech Republic · Updated on 2025-05-22
80
Participants Needed
1
Research Sites
248 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Reversibility of Bronchial Obstruction in Children Born Preterm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 1 location
1
First faculty of Medicine, Charles university.
Prague, Czechia, 128 00
Actively Recruiting
Research Team
J
Jana Tukova, MD, PhD
CONTACT
Y
Yotam Ophir, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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