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Reversibility of Bronchial Obstruction in Children Born Preterm

NCT06110481 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2025-05-22

No results posted yet for this study

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).

Conditions

  • Bronchopulmonary Dysplasia
  • Chronic Lung Disease of Prematurity
  • Chronic Lung Disease of Newborn
  • Preterm Birth Complication
  • Bronchial Hyperreactivity
  • Bronchial Obstruction
  • Reversible Dilatation

Sponsors & Collaborators

  • Charles University, Czech Republic

    lead OTHER

Principal Investigators

  • Jana Tukova, MD,PhD · Charles University, Czech Republic First Faculty of Medicine, Prague

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2025-12-01
Completion
2026-01-01

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06110481 on ClinicalTrials.gov