Trial · NCT03623698
Nebulised Hypertonic Saline in Children and Young People With Neuromuscular Disease and Cerebral Palsy
NCT03623698, Completed, Imperial College London; results first posted 2020-09-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nebulised Hypertonic Saline in Children and Young People With Neuromuscular Disease and Cerebral Palsy. Trials, record NCT03623698. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03623698
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nebulised Hypertonic Saline in Children and Young People With Neuromuscular Disease and Cerebral Palsy
- NCT number
- NCT03623698
- Status
- Completed
- Enrollment
- 24 participants, actual
- Lead sponsor
- Imperial College London
- Conditions
- Neuromuscular Diseases
- Interventions
- Nebulised hypertonic saline
- First posted
- 2018-08-09
- Last updated
- 2020-09-16
- Results first posted
- 2020-09-16
- Limitations and caveats
This was a retrospective study, with potential for bias from self-selection. Each patient was used as their own control. The use of questionnaires had the potential for recall bias. This study did not have adherence data.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Antibiotic Courses | Change from baseline (before treatment) and 12 months after treatment | Treatments due to respiratory exacerbations |
| Primary | Number of Hospitalsations Due to Respiratory Exacerbations | Change from baseline (before treatment) and 12 months after treatment | Number of respiratory exacerbations that required not planned hospitalisation |
| Secondary | Participant's Perception of Treatment | At 12 months after starting treatment with hypertonic saline | Questionnaire: "Hypertonic saline treatment questionnaire". Perception of overall usefulness of nebulised hypertonic saline: "Useful", "Not useful", "I don't know". |
| Secondary | Parent's or Legal Guardian's Perception of Treatment | At 12 months after starting treatment with hypertonic saline | "Hypertonic saline treatment questionnaire for legal guardian". Measures the perception of overall usefulness of nebulised hypertonic saline through a likert scale: Very useful, useful, neither useful or not useful, not useful, not at all useful. |
| Secondary | Score on the Ease of Airway Clearance Pictorial Analogue Scale From Children and Young Adults as Participants | Change from baseline (before treatment) and 12 months after treatment | Pictorial visual scale "Facial Rating of perceived exertion Scale". Measures ease of airway clearance. Values range starting in 0 (Extremely easy) to 10 (Extremely hard), including 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10. Numbers are also associated with facial expressions. |
| Secondary | Score on the Ease of Airway Clearance From Parents or Legal Guardians | Change from baseline (before treatment) and 12 months after treatment | Measures ease of airway clearance through a 1-5 likert scale: 1) Very easy, 2) Easy, 3) Neither easy nor difficult, 4) Not easy, 5) Not at all easy. |
| Secondary | Apnea Index (AI) | Change from baseline (before treatment) and 12 months after treatment | The number of apneas recorded during the study per hour of sleep |
| Secondary | AHI | Change from baseline (before treatment) and 12 months after treatment | Nocturnal Apnoea Hipopnea index: total number of apnea events plus hypopnea events divided by the total number of minutes of actual sleep time and then multiplied by 60. |
| Secondary | %SpO2 | Change from baseline (before treatment) and 12 months after treatment | Nocturnal oxygen saturation |
| Secondary | Nocturnal ODI | Change from baseline (before treatment) and 12 months after treatment | Oxygen desaturation index: Number of desaturations per hour of sleep |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Antibiotic Courses | Change from baseline (before treatment) and 12 months after treatment | Two participants had incomplete data for this outcome, and/or their parents could not recall | Courses of antibiotics | MEDIAN |
| PRIMARY | Number of Hospitalsations Due to Respiratory Exacerbations | Change from baseline (before treatment) and 12 months after treatment | 23/24 patients were analysed for this outcome, because one patient had incomplete records on hospitalisations. | Hospitalisations | MEDIAN |
| SECONDARY | Participant's Perception of Treatment | At 12 months after starting treatment with hypertonic saline | Applied to all participants aged 10-15 years who were able to communicate their views. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Parent's or Legal Guardian's Perception of Treatment | At 12 months after starting treatment with hypertonic saline | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Score on the Ease of Airway Clearance Pictorial Analogue Scale From Children and Young Adults as Participants | Change from baseline (before treatment) and 12 months after treatment | score on a scale | MEAN | |
| SECONDARY | Score on the Ease of Airway Clearance From Parents or Legal Guardians | Change from baseline (before treatment) and 12 months after treatment | score on a scale | MEAN | |
| SECONDARY | Apnea Index (AI) | Change from baseline (before treatment) and 12 months after treatment | 3/24 patients had records for this outcome | Events per hour of sleep | MEAN |
| SECONDARY | AHI | Change from baseline (before treatment) and 12 months after treatment | Events per hour of sleep | MEAN | |
| SECONDARY | %SpO2 | Change from baseline (before treatment) and 12 months after treatment | 21/24 patients had complete records for this outcome | percentage of SpO2 | MEAN |
| SECONDARY | Nocturnal ODI | Change from baseline (before treatment) and 12 months after treatment | 21/24 patients had complete records for this outcome | Events per hour of sleep | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Antibiotic Courses | Before Treatment | Total courses of antibiotics | 4 | Inter-Quartile Range 2 to 6 | Courses of antibiotics |
| Change in Antibiotic Courses | After Treatment | Total courses of antibiotics | 1 | Inter-Quartile Range 0 to 2 | Courses of antibiotics |
| Change in Antibiotic Courses | Before Treatment | Courses of Oral antibiotics | 2.50 | Inter-Quartile Range 1.00 to 6.00 | Courses of antibiotics |
| Change in Antibiotic Courses | After Treatment | Courses of Oral antibiotics | 1.00 | Inter-Quartile Range 0.00 to 2.00 | Courses of antibiotics |
| Change in Antibiotic Courses | Before Treatment | Courses of intravenous antibiotics | 1.00 | Inter-Quartile Range 0.00 to 1.00 | Courses of antibiotics |
| Change in Antibiotic Courses | After Treatment | Courses of intravenous antibiotics | 0.00 | Inter-Quartile Range 0.00 to 0.00 | Courses of antibiotics |
| Number of Hospitalsations Due to Respiratory Exacerbations | Before Treatment | 1 | Inter-Quartile Range 0 to 2 | Hospitalisations | |
| Number of Hospitalsations Due to Respiratory Exacerbations | After Treatment | 0 | Inter-Quartile Range 0 to 0 | Hospitalisations | |
| Participant's Perception of Treatment | Children and Young People With Neuromuscular Disease | Useful | 11 | Participants | |
| Participant's Perception of Treatment | Children and Young People With Neuromuscular Disease | Not useful | 0 | Participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Children and Young People With Neuromuscular Disease | 24 | |
| Overall Study | COMPLETED | Children and Young People With Neuromuscular Disease | 24 | |
| Overall Study | NOT COMPLETED | Children and Young People With Neuromuscular Disease | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Children and Young People With Neuromuscular Disease | 0 | 0 |
| Total, other adverse events | Children and Young People With Neuromuscular Disease | 0 | 0 |
| Total, serious adverse events | Children and Young People With Neuromuscular Disease | 0 | 0 |
Source ClinicalTrials.gov
Papers11
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03623698
GET https://conductscience.org/api/trials/v1/NCT03623698/results?page=2