Respiratory AspirationBreathe-EasyNCT06039852
Acceptability and Feasibility of a New Postural Management Night-time Intervention to Improve Respiratory Health of Children With Complex Neuro-disability
A study testing Novel Postural Management Night-time Intervention in people with Respiratory Aspiration, run by Sussex Community NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This research concerns children with complex neuro-disability. Damage to the developing brain leads to lifelong disturbances in motor control, seizures, cognition, communication, eating and drinking, and behaviour. Children with complex neuro-disability are dependent upon others to move and position them. Read more about this study
- Who is it for?
- Ages 2 to 19 years
- Conditions the study is for
- Respiratory Aspiration
- What is being tested?
- Novel Postural Management Night-time Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- dependent upon others to position/move their bodies
- high risk of aspiration linked to swallowing difficulties
- aged 2-18yrs
- have gastrostomy/jejunostomy
- receiving care from Consultant Respiratory Paediatrician from Royal Alexandra Children's Hospital (Dr Kapur or colleague) because of recent history of chest infections.
Who cannot join
- Children with complex neuro-disability who cannot be positioned in such a way that promotes upper airway drainage
- Children using a naso-gastric tube
- Children who do not have a gastrostomy or jejunostomy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Chailey Clinical Services
Brighton, East Sussex, BN8 4JN
About this study
Official title: Breathe-Easy: a Pilot Study to Examine the Acceptability and Feasibility of a Novel Postural Management Night-time Intervention to Improve Respiratory Health of Children With Complex Neuro-disability.
This research concerns children with complex neuro-disability. Damage to the developing brain leads to lifelong disturbances in motor control, seizures, cognition, communication, eating and drinking, and behaviour. Children with complex neuro-disability are dependent upon others to move and position them. Children commonly experience chronic lung disease, leading to frequent hospitalisation, medical interventions and premature death. Respiratory illness may be triggered by "aspiration", i.e. when saliva, food, liquid or stomach contents enter the lungs. Aspiration risks increase at night-time when supervision is limited and children are positioned on their backs. Some children experience repeated breathing complications requiring prolonged hospital stays including respiratory support in intensive care.
Consultant Respiratory Paediatrician Akshat Kapur and Physiotherapist Hilda Perry developed a new night-time intervention to improve respiratory health of children with complex neuro-disability. Dr Kapur and his team have found that this intervention can help reduce respiratory illness and time spent in hospital for some children. This is an acceptability and feasibility study which means the investigators want to find out if this new intervention is something that children with complex neuro-disability and their families are happy (i.e. it is acceptable) and able (i.e. it is feasible) to do. If so, a larger future research study can be designed to find out if the intervention works to improve the respiratory health of children with complex neuro-disability.
Read the detailed description
The intervention involves positioning children safely on their fronts using pillows to support the body under the shoulder and hip, and with the head slightly lowered so that gravity can help drain secretions from the mouth. This is different to current night-time positioning recommendations of either lying children on their backs or side. The new intervention also involves, where possible, the draining of children's stomach contents overnight via an existing feeding tube to prevent aspiration of stomach contents.
The investigators will work closely with 10 children with complex neuro-disability and their families, and health professionals as investigators introduce this new night-time intervention. The investigators will make observations about children's respiratory and sleep outcomes before and after making changes. The investigators will make comparisons using questionnaires, sleep diaries, records of antibiotic use and hospital admissions. The investigators will collect this information before making any changes, at 3 months after the intervention has been established and after 6 months when the study ends. The investigators will talk to children, parents, carers and relevant health professionals to find out what they think and feel about the new intervention, including any issues/challenges that occurred.
The investigators will record how many children and families were approached to take part in the study. The investigators will record how many agreed to take part, how many chose to leave half way through and how many said they did not want to take part in the study. Families who discontinued or who declined the intervention will be given opportunity to provide feedback confidentially.
The investigators will use the findings to decide whether it is feasible and acceptable to children and families to run a research trial of this new night-time intervention. The data will help us to design a future research trial.
- Conditions
- Respiratory Aspiration
- Being tested
- Novel Postural Management Night-time Intervention
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Postural Management Night-time InterventionOther
Essential elements and components of PMN-TI:
- Safe and comfortable position to enable sleep
- Positioning to enable UAD overnight
- Quiet breathing unobstructed by base of tongue (i.e. stertor), vocal cords (i.e. stridor) or pooled secretions
- Postural support in lying to achieve comfort, promote symmetry of posture and maximum loadbearing
- Stomach contents reduced or emptied overnight to minimize reflux and associated aspiration risk.
| Study group | Role | What they receive |
|---|---|---|
| Novel Postural Management Night-time Intervention Components | Experimental | Intervention Arm Receives: Other: Novel Postural Management Night-time Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liverpool Respiratory Symptom Questionnaire
Questionnaire Outcome Measure
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Apr 2021
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory AspirationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sussex Community NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Crombie, PhD, Principal investigator, Sussex Community NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039852
- Sponsor's protocol ID
- 288217
- Acronym
- Breathe-Easy
- Status last verified
- Mar 2025
- First submitted
- 8 Sep 2023
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathe-Easy: a Pilot Study to Examine the Acceptability and Feasibility of a Novel Postural Management Night-time Intervention to Improve Respiratory Health of Children With Complex Neuro-disability.
- ClinicalTrials.gov ID
- NCT06039852
- Acronym / sponsor ID
- Breathe-Easy / 288217
- Conditions
- Respiratory Aspiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sussex Community NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research concerns children with complex neuro-disability. Damage to the developing brain leads to lifelong disturbances in motor control, seizures, cognition, communication, eating and drinking, and behaviour. Children with complex neuro-disability are dependent upon others to move and position them. Children commonly experience chronic lung disease, leading to frequent hospitalisation, medical interventions and premature death. Respiratory illness may be triggered by "aspiration", i.e. when saliva, food, liquid or stomach contents enter the lungs. Aspiration risks increase at night-time when supervision is limited and children are positioned on their backs. Some children experience repeated breathing complications requiring prolonged hospital stays including respiratory support in intensive care.
Consultant Respiratory Paediatrician Akshat Kapur and Physiotherapist Hilda Perry developed a new night-time intervention to improve respiratory health of children with complex neuro-disability. Dr Kapur and his team have found that this intervention can help reduce respiratory illness and time spent in hospital for some children. This is an acceptability and feasibility study which means the investigators want to find out if this new intervention is something that children with complex neuro-disability and their families are happy (i.e. it is acceptable) and able (i.e. it is feasible) to do. If so, a larger future research study can be designed to find out if the intervention works to improve the respiratory health of children with complex neuro-disability.
Detailed description
The intervention involves positioning children safely on their fronts using pillows to support the body under the shoulder and hip, and with the head slightly lowered so that gravity can help drain secretions from the mouth. This is different to current night-time positioning recommendations of either lying children on their backs or side. The new intervention also involves, where possible, the draining of children's stomach contents overnight via an existing feeding tube to prevent aspiration of stomach contents.
The investigators will work closely with 10 children with complex neuro-disability and their families, and health professionals as investigators introduce this new night-time intervention. The investigators will make observations about children's respiratory and sleep outcomes before and after making changes. The investigators will make comparisons using questionnaires, sleep diaries, records of antibiotic use and hospital admissions. The investigators will collect this information before making any changes, at 3 months after the intervention has been established and after 6 months when the study ends. The investigators will talk to children, parents, carers and relevant health professionals to find out what they think and feel about the new intervention, including any issues/challenges that occurred.
The investigators will record how many children and families were approached to take part in the study. The investigators will record how many agreed to take part, how many chose to leave half way through and how many said they did not want to take part in the study. Families who discontinued or who declined the intervention will be given opportunity to provide feedback confidentially.
The investigators will use the findings to decide whether it is feasible and acceptable to children and families to run a research trial of this new night-time intervention. The data will help us to design a future research trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novel Postural Management Night-time Intervention Components | Experimental | Other: Novel Postural Management Night-time InterventionIntervention Arm |
Who may qualify
- Ages
- 2 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- dependent upon others to position/move their bodies
- high risk of aspiration linked to swallowing difficulties
- aged 2-18yrs
- have gastrostomy/jejunostomy
- receiving care from Consultant Respiratory Paediatrician from Royal Alexandra Children's Hospital (Dr Kapur or colleague) because of recent history of chest infections.
Key exclusion criteria (3 listed)
- Children with complex neuro-disability who cannot be positioned in such a way that promotes upper airway drainage
- Children using a naso-gastric tube
- Children who do not have a gastrostomy or jejunostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel Postural Management Night-time InterventionEssential elements and components of PMN-TI: * Safe and comfortable position to enable sleep * Positioning to enable UAD overnight * Quiet breathing unobstructed by base of tongue (i.e. stertor), vocal cords (i.e. stridor) or pooled secretions * Postural support in lying to achieve comfort, promote symmetry of posture and maximum loadbearing * Stomach contents reduced or emptied overnight to minimize reflux and associated aspiration risk. | Other | Novel Postural Management Night-time Intervention Components |
Primary outcome
Liverpool Respiratory Symptom Questionnaire
Time frame: 2 years
Questionnaire Outcome Measure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Crombie, PhD principal investigator
Sussex Community NHS FT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Postural Management Night-time Intervention in people with Respiratory Aspiration, run by Sussex Community NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liverpool Respiratory Symptom Questionnaire (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.