Respiratory Oscillometry Norms for Polish Children and Adolescent.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-10

Study Completion Date

2025-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to establish normative values for respiratory oscillometry in the Polish pediatric population. It is designed as a multicentre, population-based, prospective cohort study including children and adolescents aged 3-18 years. The results will provide reference standards for respiratory oscillometry that may support the diagnosis and monitoring of respiratory diseases in clinical practice and research.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Investigation of Lungfunction Normal Values in Children and Adolescent in Germany (Spirometry, Ultrasonic Pneumography and Exhaled NO)

NCT00723619

Healthy

COMPLETED

Exercise-induced Bronchoconstriction in School Children

NCT01798823

Asthma

UNKNOWN

Biomarkers and Respiratory Omics as New CHildren Opportunities - Study of Clinical Outcomes and Predictivity Evaluation

NCT07232550

Asthma in Children Protracted Bacterial Bronchitis Chronic Cough

NOT_YET_RECRUITING

Breath Analysis in Children by New Point-of-care Instruments

NCT03377686

Asthma Cystic Fibrosis

COMPLETED

Interpreting Respiratory Oscillometry in Adult Asthma and COPD: a Delphi Study

NCT06313372

Asthma Chronic Obstructive Pulmonary Disease

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

OSCILLONiCA-PL-Kids is a multicentre, observational, cross-sectional study designed to establish normative reference values for respiratory oscillometry (IOS) in healthy Polish children and adolescents aged 3-18 years. The study is coordinated by the Polish Society of Pediatric Pulmonology and conducted in 12 pediatric centers across Poland between 2023 and 2025.

Standardized Jaeger oscillometry systems (ERS-validated) are used across all sites, following harmonized operating procedures. All investigators and technicians undergo centralized training and certification, with periodic audits and refresher sessions to ensure procedural consistency and data quality. Measurements are performed during tidal breathing with cheek support and a nose clip, recording at least three technically acceptable trials per participant. Parameters include resistance (Rrs) and reactance (Xrs) at 5, 10, and 20 Hz, resonance frequency (Fres), and area of reactance (AX).

Anthropometric data (height, weight, age, sex) are collected simultaneously to allow modeling of predicted values. Data integrity is verified using automated quality-control algorithms. Reference equations for oscillometric parameters will be derived using generalized additive models for location, scale, and shape (GAMLSS, LMS method). Model performance will be evaluated using the Schwarz Bayesian Criterion, with sensitivity analyses assessing robustness to borderline cases and environmental exposures.

Raw measurement data, as well as derived parameters (means, standard deviations, percentiles, and z-scores), will be used to generate normative reference values and percentile charts stratified by age, height, and sex.

Quality assurance: Data collection and management follow standardized operating procedures (SOPs) approved by the coordinating center. Each site conducts internal data validation prior to upload, and periodic cross-site audits are performed to ensure compliance and consistency. Automatic range and logic checks are implemented in the database to flag out-of-range or inconsistent entries.

Missing data plan: Incomplete or invalid recordings will be excluded from normative modeling. Sensitivity analyses will evaluate the impact of missing data on reference equations. Imputation will not be used for normative dataset derivation.

The study adheres to ERS Technical Standards for Oscillometry (2020) and complies with Good Clinical Practice for observational research. The resulting reference equations and percentile charts will provide validated normative standards for pediatric oscillometry in Poland and support future international harmonization efforts.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Pulmonary Function Test

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

4\. Written informed consent from a parent/legal guardian (for participants \<16 years) or from the participant if ≥16 years.

\-

Exclusion Criteria

2\. Acute respiratory infection within 4 weeks before testing. 3. Severe chronic comorbidities (e.g., congenital heart disease, neuromuscular disorders).

4\. Chest deformation 5. Inability to perform oscillometry according to ERS standards.

\-

Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes