Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mechanical Cough Augmentation in Children With NMD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03831568
Recruitment Status : Completed
First Posted : February 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborators:
University Hospital of North Norway
St. Olavs Hospital
Haukeland University Hospital
Helse Stavanger HF
Sorlandet Hospital HF
Information provided by (Responsible Party):
Brit Hov, Oslo University Hospital

Tracking Information
First Submitted Date November 27, 2017
First Posted Date February 6, 2019
Last Update Posted Date September 6, 2019
Actual Study Start Date January 1, 2018
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 4, 2019)
  • Residency [ Time Frame: At one point (1 day) ]
    Name of county
  • Indication for use [ Time Frame: At one point (1 day) ]
    Prevention or treatment purposes from questionnaire
  • Diagnosis [ Time Frame: 01.01.2018 ]
    International Classification of Diseases - 10 diagnosis
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03831568 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 4, 2019)
  • Health related quality of life [ Time Frame: One time at completion of questionaire ]
    The DISABKIDS Chronic Generic Module (DCGM‐37) is a questionnaire measuring general health-related quality of life (HRQoL) and the level of distress caused by a chronic disease at 3 domains (mental, social and physical) in 6 dimensions: Independence, Emotion, Social inclusion, Social exclusion, Limitation and Treatment. Each item is scored on a five‐point Likert scale which indicates behavior or feelings as 1 = never, 2 = seldom, 3 = quite often, 4 = very often and 5 = always. There is one form to be filled in by children 8 to 18 years of age, and one form by their parents. The sum of scores within each dimension makes up the raw score, which is transformed linearly into a score ranging from 0 to 100. The scores are added and further transformed into a total HRQOL score with a range 0 to 100 with higher scores indicating higher HRQOL.
  • Settings in use [ Time Frame: One time at completion of questionaire ]
    Recorded from data card in MIE machine
  • Opinion on treatment [ Time Frame: One time at completion of questionaire ]
    A purpose made questionnaire including questions with predefined categorical data in no order, and 2 questions using a Visual Analog Scale 0-10 to score perceived benefit of the treatment where 0 indicates not important at all and 10 indicates very important.
Original Secondary Outcome Measures
 (submitted: February 4, 2019)
  • Health related quality of life [ Time Frame: One time at completion of questionaire ]
    DisabKids HRQoL questionnaire
  • Settings in use [ Time Frame: One time at completion of questionaire ]
    Recorded from data card in MIE machine
  • Opinion on treatment [ Time Frame: One time at completion of questionaire ]
    From self-made questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mechanical Cough Augmentation in Children With NMD
Official Title Prevalence and Use of Mechanical Cough Augmentation in Children With Neuromuscular Disorders in Norway
Brief Summary The study investigates the prevalence and use of mechanical insufflation - exsufflation (MI-E) in children with Neuromuscular disorders (NMD) in Norway. The NMD related prevalence of MIE use in Norway will be described and possible regional differences regarding use will be assessed.
Detailed Description

Neuromuscular diseases (NMD) in children are severe, possibly life-threatening orphan conditions. Respiratory tract infections and lung complications are the main causes of increased morbidity and mortality.

The use of mechanical cough augmentation with insufflation-exsufflation (MIE) is a strategy to treat and prevent. Possible major benefits are described, but optimal settings for best efficacy and comfort in children are not established.

The main objective is to determine the prevalence and use of MIE among children with NMD in Norway. All children with NMD < 18 years which has received a machine for MI-E will be invited to participate in the study.

The participants will be asked to complete two questionnaires. In addition will information from the data card in the MI-E machines give information about use. The information will be linked to the National register for Long term mechanical ventilation.

Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 1 Day
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Children with neuromuscular disorder bellow 18 years that has received a machine for MI-E.
Condition
  • Neuromuscular Diseases
  • Children, Only
  • Airway Clearance Impairment
  • Cough
Intervention Not Provided
Study Groups/Cohorts Children with given device for mechanical cough
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 4, 2019)
72
Original Actual Enrollment Same as current
Actual Study Completion Date January 31, 2019
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria: ,

  • Received a MI-E device
  • Neuromuscular disease
  • < 18 years

Exclusion Criteria:

- None

Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT03831568
Other Study ID Numbers MIE 2016_14321
17/9232 ( Registry Identifier: NPR )
Hov_2017 ( Registry Identifier: NR LTMV )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Brit Hov, Oslo University Hospital
Study Sponsor Oslo University Hospital
Collaborators
  • University Hospital of North Norway
  • St. Olavs Hospital
  • Haukeland University Hospital
  • Helse Stavanger HF
  • Sorlandet Hospital HF
Investigators
Principal Investigator: Vegard Hovland, PhD MD
PRS Account Oslo University Hospital
Verification Date September 2019