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

• Sponsor: University Hospital Inselspital, Berne (Other)
• Overall Status: Completed
• CT.gov ID: NCT04016194
• Collaborator: Lindenhofspital (Other)
• Enrollment: 200
• Locations: 2
• Actual Duration (Months): 191
• Patients Per Site: 100
• Patients Per Site Per Month: 0.5

Study Details

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	Phase
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

• 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: Jan 1, 1990
• Actual Primary Completion Date: Dec 1, 2005
• Actual Study Completion Date: Dec 1, 2005

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

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

   Anthropometric characteristics

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

   Anthropometric characteristics

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

   Clinical characteristics

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Children's Hospital Bern	Bern		Switzerland	3007
2	Lindenhof Spital, Quartier Bleu	Bern		Switzerland	3012

Sponsors and Collaborators

• University Hospital Inselspital, Berne
• Lindenhofspital

Investigators

• Principal Investigator: Florian Singer, University Hospital Inselspital, Berne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital Inselspital, Berne
• ClinicalTrials.gov Identifier: NCT04016194
• Other Study ID Numbers: 3840
• First Posted: Jul 11, 2019
• Last Update Posted: Jul 11, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital Inselspital, Berne: Multiple-breath washout, MBW; Lung clearance index, LCI; Prediction; Survival; Cystic Fibrosis, CF
• Additional relevant MeSH terms: Cystic Fibrosis; Fibrosis

Study Results

No Results Posted as of Jul 11, 2019