Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06039852 |
| Other study ID # |
288217 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2021 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Sussex Community NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
