Pulmonary Function and Neuromuscular Disease (PREMDEN)

August 16, 2018 updated by: Centre Hospitalier Universitaire de Besancon
This study aims to describe the evolution of pulmonary function in 3 neuromuscular diseases : Duchenne muscular dystrophy, Werdnig-Hoffinann disease, congenital myopathy, monitored in Besançon university hospital.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France
        • CHU de Besancon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children suffering from neuromuscular diseases and followed-up in Besançon University Hospital between 2006/01/01 and the beginning of this study

Description

Inclusion Criteria:

  • Neuromuscular disease
  • Followed-up in Besançon University Hospital
  • With at least 2 Pulmonary Function Tests previously performed

Exclusion Criteria:

  • Mental deficiency
  • Facial expressions disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FVC (Forced Vital Capacity)
Time Frame: Year 12
Percentage of decrease of FVC sitting or lying down
Year 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2018

Primary Completion (Actual)

February 10, 2018

Study Completion (Actual)

February 10, 2018

Study Registration Dates

First Submitted

February 20, 2018

First Submitted That Met QC Criteria

February 23, 2018

First Posted (Actual)

February 26, 2018

Study Record Updates

Last Update Posted (Actual)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 16, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2017/346

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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