Prediction of Survival in Children With Cystic Fibrosis Using the Multiple-breath Washout

Completed

• Conditions: Death; Lung Transplantation; Cystic Fibrosis

• Registration Number: NCT04016194
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

Retrospective cohort study using routinely collected annual data on lung clearance index (LCI) in combination with clinical data to predict survival in patients with Cystic Fibrosis. The primary study endpoint is the association of LCI with the compound outcome survival or lung transplantation in patients with CF.

Detailed Description

Retrospective analysis of longitudinal data collected during clinically routine from approximately 200 patients with CF aged 3 years or more between 01.01.1980 and 31.12.2005. The overall aim of this project is to retrospectively assess whether LCI measured for clinical purposes during school age is predictive for survival or lung transplantation in adulthood. For this, the investigators will assess in a systematic way clinically measured LCI and relate them with the compound outcome survival or lung transplantation retrospectively.

Study Timeline

• Study Start: 1990-01-01
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Study First Submitted: 2019-05-07
• Status Verified: 2019-07
• Study First Submitted QC: 2019-07-09
• Last Update Submitted: 2019-07-09
• Study First Posted: 2019-07-11
• Last Update Posted: 2019-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients treated at the Children's Hospital Bern
• Confirmed CF Diagnosis
• Age >= 3 years

Exclusion Criteria

• Uncertain diagnosis of CF according to current standards
• Existing written or otherwise documented refusal to participate in research

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lung clearance index (LCI)	Lung function is collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached	Lung function outcome derived by MBW and the compound Outcomes mortality or lung transplantation

Secondary Outcome Measures

Name	Time	Method
Functional residual capacity (FRC)	Lung function is collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached	Lung function outcome derived by MBW
Forced expired Volume in 1 second (FEV1)	Lung function is collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached	Lung function outcome derived by Spirometry
Body weight	Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached	Anthropometric characteristics
Body length	Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached	Anthropometric characteristics
Gender	Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached	Anthropometric characteristics
Presence of Pseudomonas aeruginosa infection	Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached	Clinical characteristics
Presence of Staphylococcus aureus infection	Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached	Clinical characteristics

Trial Locations

Locations (2)

University Children's Hospital Bern; 🇨🇭 Bern, Switzerland

Lindenhof Spital, Quartier Bleu; 🇨🇭 Bern, Switzerland