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Mechanical Insufflation -Exsufflation in Children With NMD and Weak Cough

NCT04081116 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2023-01-20

No results posted yet for this study

Summary

Neuromuscular diseases (NMD) in children are severe, possibly life-threatening orphan conditions. The children are vulnerable and often subject to rapid deterioration of pulmonary function due to impaired ability to clear airway secretions. 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 project aim to improve the quality of the treatment with MIE in children with NMD and weak cough. On the basis of a bench study a clinical trial aims to examine the most effective MIE settings when used in stable state and when respiratory tract infections are present.

Conditions

  • Neuromuscular Diseases in Children

Interventions

OTHER

Symmetric settings (high pressures/fast rate)

Describes settings on the MI-E device

OTHER

Asymmetric settings (Pi<Pe/Ti>Te)

Lower insufflation pressures at longer times

OTHER

Preinclusion settings

Settings in use at start of study

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2021-02-28
Completion
2021-02-28

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04081116 on ClinicalTrials.gov