Reversibility of Bronchial Obstruction in Children Born Preterm

NCT06110481 | Recruiting

• 1 other identifier: CZ-VFN-PEDMET-BPD-001
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (3)

• Change of spirometric parameters of bronchial obstruction in children born preterm to inhaled salbutamol, ipratropium bromide and combination of fenoterol with ipratropium bromide

  Spirometric parameters of bronchial obstruction before and after inhaled application of bronchodilator during check-up. Three types of bronchodilators (salbutamol, ipratropium bromide and combined inhaler of fenoterol with ipratropium bromide) at three different check-ups will be tested with the order selected by randomisation. Z-score of baseline (pre-interventional) spirometric expiratory flow parameters (MMEF (l/s), MEF75 (l/s), MEF50 (l/s), MEF25 (l/s) retrieved from flow-volume curve compared to post-interventional z- scores of MMEF (l/s), MEF75 (l/s), MEF50 (l/s), MEF25 (l/s) values measured after a predefined time interval specific to bronchodilator (15-30 minutes). Four standardised doses of bronchodilators will be administered with metered-dose inhaler by spacer without a mask.

  baseline and post-interventional spirometry after 15-30 minutes (interval specific to bronchodilator) during three check-ups with min. time interval between check-ups 24 hours and max. 30 days

• Change of spirometric parameters of lung volume in children born preterm to inhaled salbutamol, ipratropium bromide and combination of fenoterol with ipratropium bromide

  Spirometric parameters of lung volume before and after inhaled application of bronchodilator during check-up. Three types of bronchodilators (salbutamol, ipratropium bromide and combined inhaler of fenoterol with ipratropium bromide) at three different check-ups will be tested with the order selected by randomisation. Z-score of baseline (pre-interventional) spirometric volume parameters FEV 0.5 (ml), FVC (ml) retrieved from flow-volume curve compared to post-interventional z- scores of FEV 0.5 (l), FVC (l) values measured after a predefined time interval specific to bronchodilator (15-30 minutes). Four standardised doses of bronchodilators will be administered with metered-dose inhaler by spacer without a mask.

  baseline and post-interventional spirometry after 15-30 minutes (interval specific to bronchodilator) during three check-ups with min. time interval between check-ups 24 hours and max. 30 days

• Change of area under the flow-volume spirometric curve in children born preterm to inhaled salbutamol, ipratropium bromide and combination of fenoterol with ipratropium bromide

  Complex spirometric parameter of area under the curve before and after inhaled application of bronchodilator during check-up. Three types of bronchodilators (salbutamol, ipratropium bromide and combined inhaler of fenoterol with ipratropium bromide) at three different check-ups will be tested with the order selected by randomisation. Z-score of baseline (pre-interventional) Aex (l\*l/s) retrieved from flow-volume curve compared to post-interventional z- scores of Aex (l\*l/s) values measured after a predefined time interval specific to bronchodilator (15-30 minutes). Four standardised doses of bronchodilators will be administered with metered-dose inhaler by spacer without a mask.

  baseline and post-interventional spirometry after 15-30 minutes (interval specific to bronchodilator) during three check-ups with min. time interval between check-ups 24 hours and max. 30 days

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

children born preterm before 35+0 of gestational age (35+0) with chronic lung disease of prematurity with bronchial obstruction, confirmed by spirometry.

You may qualify if:

• 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 may not qualify if:

• Insufficient cooperation during spirometry.

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

First faculty of Medicine, Charles university.

Prague, 128 00, Czechia

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Bronchial Hyperreactivity

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bronchial Diseases

Study Officials

• Jana Tukova, MD,PhD

  Charles University, Czech Republic First Faculty of Medicine, Prague

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jana Tukova, MD, PhD

CONTACT

+420608116653; tukovajana@seznam.cz

Yotam Ophir, MD

CONTACT

+420608199927; yotkeofire@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: October 31, 2023
• Study Start: April 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2024-10

Locations

CZ (1)