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Acceptability and Feasibility of a New Postural Management Night-time Intervention to Improve Respiratory Health of Children With Complex Neuro-disability

NCT06039852 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-03-25

No results posted yet for this study

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.

Conditions

  • Respiratory Aspiration

Interventions

OTHER

Novel Postural Management Night-time Intervention

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.

Sponsors & Collaborators

  • Sussex Community NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Sarah Crombie, PhD · Sussex Community NHS FT

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06039852 on ClinicalTrials.gov