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

NCT ID: NCT04016194

Last Updated: 2019-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

1990-01-01

Study Completion Date

2005-12-31

Brief Summary

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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

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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.

Conditions

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Cystic Fibrosis Death Lung Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Multiple-breath washout, MBW

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lindenhofspital

UNKNOWN

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florian Singer

Role: PRINCIPAL_INVESTIGATOR

Insel Gruppe AG, University Hospital Bern

Locations

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University Children's Hospital Bern

Bern, , Switzerland

Site Status

Lindenhof Spital, Quartier Bleu

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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Kurz JM, Ramsey KA, Rodriguez R, Spycher B, Fischer Biner R, Latzin P, Singer F. Association of lung clearance index with survival in individuals with cystic fibrosis. Eur Respir J. 2022 Mar 3;59(3):2100432. doi: 10.1183/13993003.00432-2021. Print 2022 Mar.

Reference Type DERIVED
PMID: 34289977 (View on PubMed)

Other Identifiers

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3840

Identifier Type: -

Identifier Source: org_study_id

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