CompletedNot Applicable

Mechanical Insufflation -Exsufflation in Children With NMD and Weak Cough

Norway77 participantsStarted 2019-01-01

Plain-language 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.

Who can participate

Age range6 Months – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosed neuromuscular disease \< 18 years * Established use (\> 3mnd) of MI-E. * Reduced PCF * PCF \< 270 l/min (when \> 12 years) * \< 5th percentiles for PCF 16 (when 4 - 12 years) * Clinical indication (difficulty to clear secretions, audible weak cough, history of pneumonia or frequent or prolonged respiratory tract infections). Exclusion Criteria: * age \< 6 mnd * obstructive lung disease (hyperinflation or emphysema on x-ray.

What they're measuring

PCF in the MI-E circuit

Timeframe: 30 minutes.

Patient reported comfort

Timeframe: Total time use 30 min

Trial details

NCT IDNCT04081116

SponsorOslo University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-02-28

View on ClinicalTrials.gov More Neuromuscular Diseases in Children trials