Skip to main content
OpenTrials
Completed

NCT Number: NCT04016194

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Death Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Lung Transplantation Pancreatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

3 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lindenhof Spital, Quartier Bleu, Bern, Switzerland

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lung function testing

Diagnostic Test

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 names: Multiple-breath washout, MBW

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Lindenhofspital

Registry information

Official study title

Multiple-breath Washout for Lung Function Testing in Children With Cystic Fibrosis: Predictive for Survival?

Important dates

Study start
1990
Primary completion
2005
Study completion
2005
First posted
Jul 11, 2019
Registry last updated
Jul 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.