Status:
NOT_YET_RECRUITING
Nebulised Hypertonic Saline to Decrease Respiratory Exacerbations in Neuromuscular Disease or Neurodisability
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Nottingham University Hospitals NHS Trust
Royal Brompton & Harefield NHS Foundation Trust
Conditions:
Neuromuscular Diseases
Neurodevelopmental Disorders
Eligibility:
All Genders
5+ years
Phase:
NA
Brief Summary
Research Aim: This study investigates whether a 12-month treatment with hypertonic saline (salty water) can reduce antibiotic use in individuals with neuromuscular disease or cerebral palsy who freque...
Eligibility Criteria
Inclusion
- Diagnosis of NMD or neurodisablity by a physician independent of the study, on standard criteria.
- Age 5 years and above, including adults.
- Must be able to tolerate nebulised 6% hypertonic saline.
- Must have a history of at least one respiratory exacerbation requiring antibiotic treatment with or without the need for hospitalisation in the 12 months prior to recruitment.
Exclusion
- Patients with additional diagnosis, for example, CF, but those with aspiration and/or bronchiectasis secondary to respiratory complications of NMD will be included.
- Patients who are already prescribed daily HS in any concentration (i.e, 3%, 5%, 6%, 7%) will be excluded, but those who are on daily NS or have HS prescribed as part of their escalation plan (i.e., PRN) will be included.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06134401
Start Date
June 1 2025
End Date
December 1 2027
Last Update
October 15 2024
Active Locations (2)
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1
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
2
Nottingham University Hospitals
Nottingham, United Kingdom, NG7 2UH