Post-operative recovery in children with severe neurological impairment

Post-operative Changes in Children With Severe Neurological Impairment

This pilot will see if a set of outcome measures and caregiver interviews can be used to track recovery after major spine or hip surgery in children aged 5–18 with severe neurological impairment.

Quick facts

• Study type: Observational
• Enrollment: 17 (estimated)
• Ages: 5 Years to 18 Years
• Sex: All
• Sponsor: University of British Columbia (other)
• Locations: 1 site (Vancouver, British Columbia)
• Trial ID: NCT07121660 on ClinicalTrials.gov

What this trial studies

This is an observational pilot conducted at BC Children's Hospital that follows children with severe neurological impairment through the peri-operative period after major spine or hip surgery. The team will record feasibility metrics such as consent rate, protocol delivery, and completion of outcome measures, and will conduct end-of-study interviews with caregivers to judge acceptability. Functional status and quality of life measures will be collected alongside a neurotypically developing control group undergoing similar surgeries to explore patterns of recovery. The protocol is non-interventional and focuses on measurement and caregiver experience rather than changing clinical care.

Who should consider this trial

Good fit: Children aged 5–18 with severe neurological impairment (GMFCS II–V and CFCS II–V) who are scheduled for a major (>90 minute skin-to-skin) spine or hip surgery at BC Children's Hospital.

Not a fit: Children who are neurotypically developing (GMFCS I/CFCS I), younger than 5 or older than 18, non-English-speaking families, or those undergoing minor or non-spine/hip procedures are unlikely to benefit from this study's findings.

Why it matters

Potential benefit: If successful, the protocol could provide a reliable way to track post-operative functional recovery and guide better peri-operative planning for children with severe neurological impairment.

How similar studies have performed: Similar observational approaches to measure peri-operative recovery have been feasible in other pediatric surgical populations, but there is limited prior data specifically focused on children with severe neurological impairment.

Eligibility criteria

Inclusion Criteria for Study Participants

1. Children with severe neurological impairment (SNI), including Gross Motor Function Classification System (GMFCS) levels II, III, IV and V and Communication Function Classification System (CFCS) levels II, III, IV and V, and;
2. undergoing major orthopaedic surgical management of musculoskeletal pathology (spine or hip; major defined as \>90 minute procedure with skin-to-skin contact) at the BC Children's Hospital and;
3. between 5 and 18 years at the time of their surgical procedure

Exclusion Criteria for Study Participants:

1. GMFCS level = I and CFCS level = I
2. Non-English-speaking Parents/Caregivers

Inclusion Criteria for Control Group Participants:

1. Neurotypically developing children (GMFCS I and CFCS I) and;
2. undergoing major orthopaedic surgical management of musculoskeletal pathology (spine or hip; major defined as \>90 minute procedure with skin-to-skin contact) at the BC Children's Hospital and;
3. Between 5 and 18 years of age at the time of their surgical procedure

Exclusion Criteria for Control Group Participants:

1\) Non-English-speaking parents/caregivers

Where this trial is running

Vancouver, British Columbia

• BC Children's Hospital Research Institute — Vancouver, British Columbia, Canada (RECRUITING)

Study contacts

• Principal investigator: Hal Siden — Department of Pediatrics, UBC
• Study coordinator: Anne-Mette Hermansen

Conditions: Post-operative Functional Decline, Severe Neurological Impairment, Post-operative functional decline, Neuroinflammation