NCT03831568

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

1.1 years

First QC Date

November 27, 2017

Last Update Submit

September 4, 2019

Conditions

Neuromuscular DiseasesChildren, OnlyAirway Clearance ImpairmentCough

Keywords

Airway managementCoughNeuromuscular diseasesPediatricsMechanical insufflation-exsufflation

Outcome Measures

Primary Outcomes (3)

  • Residency

    Name of county

    At one point (1 day)

  • Indication for use

    Prevention or treatment purposes from questionnaire

    At one point (1 day)

  • Diagnosis

    International Classification of Diseases - 10 diagnosis

    01.01.2018

Secondary Outcomes (3)

  • Health related quality of life

    One time at completion of questionaire

  • Settings in use

    One time at completion of questionaire

  • Opinion on treatment

    One time at completion of questionaire

Study Arms (1)

Children with given device for mechanical cough

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children with neuromuscular disorder bellow 18 years that has received a machine for MI-E.

You may qualify if:

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

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo university hospital

Oslo, Norway

Location

MeSH Terms

Conditions

Neuromuscular DiseasesCough

Condition Hierarchy (Ancestors)

Nervous System DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Vegard Hovland, PhD

    MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, MSc

Study Record Dates

First Submitted

November 27, 2017

First Posted

February 6, 2019

Study Start

January 1, 2018

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

September 6, 2019

Record last verified: 2019-09

Locations

NO(1)