Neuromuscular DiseasesNCT03831568
Mechanical Cough Augmentation in Children With NMD
An observational study of Neuromuscular Diseases and Children, Only, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Neuromuscular Diseases, Children, Only, Airway Clearance Impairment
- How many people
- 72 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2018to 31 Jan 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with neuromuscular disorder bellow 18 years that has received a machine for MI-E.
Who may be able to join
- Received a MI-E device
- Neuromuscular disease
- < 18 years
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Use of Mechanical Cough Augmentation in Children With Neuromuscular Disorders in Norway
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.
Read the 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.
- Keywords
- Airway management, Cough, Neuromuscular diseases, Pediatrics, Mechanical insufflation-exsufflation
- Medical subject headings
- Neuromuscular Diseases, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with given device for mechanical cough | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residency
Name of county
Measured: At one point (1 day)
Indication for use
Prevention or treatment purposes from questionnaire
Measured: At one point (1 day)
Diagnosis
International Classification of Diseases - 10 diagnosis
Measured: 01.01.2018
Secondary outcomes (3)
Health related quality of life
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.
Measured: One time at completion of questionaire
Settings in use
Recorded from data card in MIE machine
Measured: One time at completion of questionaire
Opinion on treatment
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.
Measured: One time at completion of questionaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start1 Jan 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of North Norway, St. Olavs Hospital, Haukeland University Hospital, Helse Stavanger HF, Sorlandet Hospital HF
- Responsible party
- Principal investigator, Brit Hov, Oslo University Hospital
- Investigators
- Vegard Hovland, PhD, Principal investigator, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831568
- Sponsor's protocol ID
- MIE 2016_14321
- Other IDs
- 17/9232, Hov_2017
- Status last verified
- Sep 2019
- First submitted
- 27 Nov 2017
- Last updated
- 6 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Use of Mechanical Cough Augmentation in Children With Neuromuscular Disorders in Norway
- ClinicalTrials.gov ID
- NCT03831568
- Acronym / sponsor ID
- MIE 2016_14321
- Keywords
- Airway management, Cough, Neuromuscular diseases, Pediatrics, Mechanical insufflation-exsufflation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University Hospital of North Norway, St. Olavs Hospital, Haukeland University Hospital, Helse Stavanger HF, Sorlandet Hospital HF
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with given device for mechanical cough | – | – |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with neuromuscular disorder bellow 18 years that has received a machine for MI-E.
Key inclusion criteria (3 listed)
- Received a MI-E device
- Neuromuscular disease
- < 18 years
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Health related quality of life
Time frame: One time at completion of questionaire
Settings in use
Time frame: One time at completion of questionaire
Opinion on treatment
Time frame: One time at completion of questionaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
Related trials for Neuromuscular Diseases
Not yet recruitingPhase 1
A Study of Single Ascending Doses of NI112 in Adults With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Not yet recruitingObservational study
Correlation Between Forward Head Posture and Executive Functions in Cervical Radiculopathy
Cervical Radiculopathy, Forward Head Posture
RecruitingPhase 3
A Phase 3 Study to Evaluate Claseprubart in Adults With Generalized Myasthenia Gravis (EMERGE)
Myasthenia Gravis, Generalized
Not yet recruiting
Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain
Neuropathic Pain, Chronic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vegard Hovland, PhD principal investigator
MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Diseases and Children, Only, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residency (time frame: At one point (1 day)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.