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出境医 / 临床实验 / Prediction of Survival in Children With Cystic Fibrosis Using the Multiple-breath Washout

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

Study Description
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.

Condition or disease Intervention/treatment
Cystic Fibrosis Death Lung Transplantation Diagnostic Test: Lung function testing

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 Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multiple-breath Washout for Lung Function Testing in Children With Cystic Fibrosis: Predictive for Survival?
Actual Study Start Date : January 1, 1990
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Lung clearance index (LCI) [ Time Frame: 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 :
  1. Functional residual capacity (FRC) [ Time Frame: 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

  2. Forced expired Volume in 1 second (FEV1) [ Time Frame: 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

  3. Body weight [ Time Frame: Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached ]
    Anthropometric characteristics

  4. Body length [ Time Frame: Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached ]
    Anthropometric characteristics

  5. Gender [ Time Frame: Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached ]
    Anthropometric characteristics

  6. Presence of Pseudomonas aeruginosa infection [ Time Frame: Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached ]
    Clinical characteristics

  7. Presence of Staphylococcus aureus infection [ Time Frame: Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached ]
    Clinical characteristics


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date May 7, 2019
First Posted Date July 11, 2019
Last Update Posted Date July 11, 2019
Actual Study Start Date January 1, 1990
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 9, 2019) 		Lung clearance index (LCI) [ Time Frame: 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 9, 2019)
  • Functional residual capacity (FRC) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached ]
    Anthropometric characteristics
  • Body length [ Time Frame: Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached ]
    Anthropometric characteristics
  • Gender [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached ]
    Clinical characteristics
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prediction of Survival in Children With Cystic Fibrosis Using the Multiple-breath Washout
Official Title Multiple-breath Washout for Lung Function Testing in Children With Cystic Fibrosis: Predictive for Survival?
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Non-Probability sample
Condition
  • Cystic Fibrosis
  • Death
  • Lung Transplantation
Intervention Diagnostic Test: Lung function testing
Multiple-breath washout (MBW) is a safe, easy and sensitive lung function test using inert gases such as Nitrogen (N2) to assess efficiency of ventilation distribution. The latter can be estimated by the lung clearance index (LCI), an established study end-point in patients with CF
Other Name: Multiple-breath washout, MBW
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 9, 2019) 		200
Original Actual Enrollment Same as current
Actual Study Completion Date December 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT04016194
Other Study ID Numbers 3840
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: IPD will be shared with researchers involved in the data collection and analysis.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Until 12/2020
Access Criteria: Researchers involved in data collection
Responsible Party University Hospital Inselspital, Berne
Study Sponsor University Hospital Inselspital, Berne
Collaborators Lindenhofspital
Investigators
Principal Investigator: Florian Singer University Hospital Inselspital, Berne
PRS Account University Hospital Inselspital, Berne
Verification Date July 2019

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