Reversibility of Bronchial Obstruction in Children Born Preterm

Launched by CHARLES UNIVERSITY, CZECH REPUBLIC · Oct 29, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how different inhaled medications can help improve breathing in children who were born prematurely and have a condition called Chronic Lung Disease of Immaturity (CLDI), which can cause bronchial obstruction (narrowing of the airways). The researchers want to find out if one type of inhaled medication works better than others, or if a combination of medications is more effective in helping these children breathe easier.

To be eligible for the study, children need to be born before 35 weeks of pregnancy and diagnosed with CLDI and bronchial obstruction, confirmed by a breathing test called spirometry. Participants will visit the clinic three times, each time receiving a different inhaled medication (either a beta2-agonist, an anticholinergic, or a combination of both). Before and after taking the medication, they will perform a breathing test to see how well their airways respond. The trial is currently recruiting participants, and it’s important that children are stable and not experiencing any acute infections during their visits.

Gender

ALL

Eligibility criteria

• 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.