Evaluating bronchodilator effectiveness in preterm children with lung issues
Bronchodilator Response To Inhaled Beta-2 Agonist and Anticholinergic Drugs in Children Born Preterm
Charles University, Czech Republic · NCT06110481
This study is testing which inhaled bronchodilator works best to help improve lung function in preterm children with breathing problems caused by Chronic Lung Disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | Charles University, Czech Republic (other) |
| Locations | 1 site (Prague) |
| Trial ID | NCT06110481 on ClinicalTrials.gov |
What this trial studies
This observational study compares the effectiveness of different inhaled bronchodilators in children born preterm who have bronchial obstruction due to Chronic Lung Disease of Immaturity (CLDI). Participants will undergo spirometry tests before and after inhalation of various bronchodilators, including beta2-agonists and anticholinergics, to assess reversibility of bronchial obstruction. The study aims to determine if any specific bronchodilator or combination is superior in improving lung function. Children will be monitored in a stable condition without acute infections during the assessments.
Who should consider this trial
Good fit: Ideal candidates are children born preterm before the 35th week of gestation who have been diagnosed with chronic lung disease and exhibit bronchial obstruction.
Not a fit: Patients with other chronic respiratory diseases, such as cystic fibrosis, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for children with chronic lung conditions resulting from preterm birth.
How similar studies have performed: While similar studies have explored bronchodilator effectiveness, this specific approach focusing on preterm children with CLDI is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Prague
- First faculty of Medicine, Charles university. — Prague, Czechia (RECRUITING)
Study contacts
- Principal investigator: Jana Tukova, MD,PhD — Charles University, Czech Republic First Faculty of Medicine, Prague
- Study coordinator: Jana Tukova, MD, PhD
- Email: tukovajana@seznam.cz
- Phone: +420608116653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Chronic Lung Disease of Newborn, Preterm Birth Complication, Bronchial Hyperreactivity, Bronchial Obstruction, Reversible Dilatation