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

NCT06039852 | Completed

• 1 other identifier: 288217
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Liverpool Respiratory Symptom Questionnaire

  Questionnaire Outcome Measure

  2 years

Study Arms (1)

Novel Postural Management Night-time Intervention Components

EXPERIMENTAL

Intervention Arm

Other: Novel Postural Management Night-time Intervention

Interventions

Novel Postural Management Night-time Intervention OTHER

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.

Novel Postural Management Night-time Intervention Components

Eligibility Criteria

• Age: 2 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sussex Community NHS Foundation Trust: lead

Study Sites (1)

Chailey Clinical Services

Brighton, East Sussex, BN8 4JN, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah Crombie, PhD

  Sussex Community NHS FT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 15, 2023
• Study Start: April 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)