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CompletedNCT03445832PREMDENUpdated Aug 17, 2018

Pulmonary Function and Neuromuscular Disease

An observational study in Neuromuscular Diseases, sponsored by Centre Hospitalier Universitaire de Besancon. Completed at 1 site in France. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2018-08-17.

Sponsored by Centre Hospitalier Universitaire de Besancon · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
21
Ages
6 Years to 17 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Neuromuscular Diseases
03

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Mental deficiency
  • Facial expressions disorders
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
21 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. FVC (Forced Vital Capacity)

    Percentage of decrease of FVC sitting or lying down

    Time frame: Year 12

06

Study locations

1 site
  • CHU de Besançon
    Besançon, France
07

Registry details

Key details

Study ID
NCT03445832
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Sponsor
First posted
Feb 26, 2018
Start date
Jan 8, 2018
Primary completion
Feb 10, 2018
Completion
Feb 10, 2018
Last update
Aug 17, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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