Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT07207720
Status:
COMPLETED
Last Update Posted:
2025-10-06
First Post:
2025-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Respiratory Oscillometry Norms for Polish Children and Adolescent.
Sponsor:
Medical University of Gdansk
Organization:
Study Overview
Official Title:
Respiratory Oscillometry - Establishing Reference Values in Polish Children and Adolescents Aged 3-18 Years (OSCILLONiCA-PL-Kids)
Status:
COMPLETED
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OSCILLONiCA-PL
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: