Status:
RECRUITING
Reversibility of Bronchial Obstruction in Children Born Preterm
Lead Sponsor:
Charles University, Czech Republic
Conditions:
Bronchopulmonary Dysplasia
Chronic Lung Disease of Prematurity
Eligibility:
All Genders
5-18 years
Brief 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 wi...
Detailed Description
1. 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 contin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06110481
Start Date
April 1 2021
End Date
January 1 2026
Last Update
May 22 2025
Active Locations (1)
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1
First faculty of Medicine, Charles university.
Prague, Czechia, 128 00