N/A
N=24
Nebulised Hypertonic Saline in Children and Young People With Neuromuscular Disease and Cerebral Palsy
Neuromuscular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03623698 ↗Enrolled (actual)
24
Serious AEs
—
Results posted
Sep 2020
Primary outcome: Primary: Change in Antibiotic Courses — 4; 1; 2.50; 1.00 Courses of antibiotics — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Nebulised hypertonic saline (Drug)
- Age
- Pediatric, Adult · 1+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Antibiotic Courses |
4; 1; 2.50; 1.00; 1.00; 0.00 | <0.001 sig |
| PRIMARY Number of Hospitalsations Due to Respiratory Exacerbations |
1; 0 | 0.001 sig |
| SECONDARY Participant's Perception of Treatment |
11; 0; 0 | — |
| SECONDARY Parent's or Legal Guardian's Perception of Treatment |
15; 9; 0; 0; 0 | — |
| SECONDARY Score on the Ease of Airway Clearance Pictorial Analogue Scale From Children and Young Adults as Participants |
6.45; 2 | 0.003 sig |
| SECONDARY Score on the Ease of Airway Clearance From Parents or Legal Guardians |
4.21; 2.13 | <0.001 sig |
| SECONDARY Apnea Index (AI) |
4.87; 0.40 | — |
| SECONDARY AHI |
8.53; 1.38 | — |
| SECONDARY %SpO2 |
96.55; 96.53 | 0.97 |
| SECONDARY Nocturnal ODI |
4.26; 3.32 | 0.09 |
| SECONDARY TcPCO2 |
5.77; 6.00 | 0.65 |
| SECONDARY FEV1/FVC %Predicted Rate of Decline |
97.37; 98.89 | — |
| SECONDARY FEV1% Predicted Rate of Decline |
-8.03; 4.00 | — |
| SECONDARY FVC% Predicted Rate of Decline |
-7.44; 7.00 | — |
| SECONDARY Peak Expiratory Flow (PEF) |
43.5; 47 | — |
Summary
Pneumonia, respiratory exacerbations, and chronic pulmonary infection are important causes of emergency admissions, hospitalisations and death in children with Neuromuscular disorders and Cerebral Palsy. Hence, there is a need for research on how to therapeutically aid airway clearance and decrease respiratory exacerbations. Studies have shown that nebulised Hypertonic Saline is well tolerated, reduces pulmonary exacerbations and improves lung function and Lung Clearance Index in patients with Cystic Fibrosis, and enhances mucociliary clearance in asthmatic patients. Nevertheless, to the investigators' knowledge, there is no available data concerning the use of nebulised Hypertonic Saline in the management of children with Neuromuscular disorders and Cerebral Palsy. This study aims to assess the effectiveness of nebulised Hypertonic Saline to decrease hospitalisations and courses of antibiotics in children with Neuromuscular disorders and Cerebral Palsy.
Eligibility Criteria
Inclusion Criteria
- Children with Neuromuscular disease or Cerebral Palsy who have been on treatment with nebulised Hypertonic Saline for at least 12 months.
Exclusion Criteria
- Children also diagnosed with cystic fibrosis.
Data sourced from ClinicalTrials.gov (NCT03623698). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.