Post-operative Changes Study

NCT07121660 | Recruiting

• 1 other identifier: H24-01880
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational pilot study is to evaluate the feasibility and acceptability of the protocol to explore the functional post-operative trajectory in a developmentally and neurologically impaired pediatric population. The main objectives of the study are:

• Objective 1: To evaluate the feasibility and acceptability of the study protocol for children and families living with severe neurological impairment (SNI). To evaluate feasibility the investigators will assess consent rate, protocol delivery and outcome completion. To evaluate acceptability, the investigators will conduct end-of-study interviews with caregivers to assess outcomes related to the ease and utility of participating in the study, including the methods of data collection.
• Objective 2: To explore patterns of recovery in children with SNI during the peri-operative period. To do this, the investigators will be be assessing function in children with SNI, quality of life in children with SNI and their families, and the profile of inflammatory biomarkers during the perioperative period. The investigators will then compare the inflammatory profile of these children with SNI against a group of neurotypical children also undergoing surgery. To assess function and quality of life of the child with SNI, the investigators will be using the Caregivers Priorities and Child Health Index of Life with Disabilities (CPCHILD) Questionnaire. Parents/caregivers will also be asked to answer two supplemental questions to provide further insight into 1) other areas of function that were not described by CPCHILD and 2) the quality of life of the caregivers. To collect information on the peri-operative inflammatory profile of the child with SNI and the control participants, the investigators will collect blood samples at different peri-operative time points.

Conditions

Post-operative Functional Decline; Severe Neurological Impairment

Keywords

Severe Neurological Impairment; Post-operative functional decline; Neuroinflammation

Outcome Measures

Primary Outcomes (2)

• To evaluate the feasibility of the study protocol for children and their families living with severe neurological impairment.

  Feasibility will be assessed using consent rate (the overall average consent rate of children/month), protocol delivery (the percent of on/off protocol children) and outcome completion (the percent of children with complete outcome measures).

  From enrollment to the end-of-study interview approximately 6 months after surgery.

• To evaluate the acceptability of the study protocol for children and their families living with severe neurological impairment.

  Acceptability will be evaluated using end-of-study interviews with caregivers to assess the ease and utility of participating in the study as it relates to our methods and data collection.

  From enrollment to the end-of-study interview approximately 6 months after surgery.

Secondary Outcomes (2)

• Assess the function in children with SNI, including exploring patterns in specific domains of gain/loss, to explore patterns of recovery in children with severe neurological impairment (SNI) during the peri-operative period.

  From enrollment to 6 months following surgery.

• Assessing the quality of life in children with SNI and their families, to explore patterns of recovery in children with severe neurological impairment (SNI) during the peri-operative period.

  From enrollment to 6 months following surgery.

Study Arms (2)

Study Participants

The study participants are the children with severe neurological impairment (SNI) undergoing major (\>90 minute procedure) orthopedic surgery to manage musculoskeletal pathology between the ages of 5 and 18 at the time of surgery and their parent/caregiver. Blood will be collected from the child with SNI (at 6 different time points: at the pre-operative assessment, at the time of surgery, 12-24 hours post-operative, 1-2 weeks post-operative, 6 weeks post-operative and 6 months post-operative). The parent/caregiver of the child will be completing the Caregivers Priorities and Child Health Index of Life with Disabilities (CPCHILD) Questionnaire and answer two supplemental questions (at the pre-operative visit, at a 6-weeks post-operative visit and a 6-month post-operative visit). At the initial pre-operative study visit, the parent/caregiver will also complete a demographics form in which demographic information of the child and the parent/caregiver will be collected.

Control Participants

The control participants group will consist of neurotypically developing children undergoing spine surgery for scoliosis between the ages of 5 and 18 at the time of their surgical procedure. The child or the parent/caregiver of the child, depending on the age of the child, will complete a demographic form and then have blood samples collected at 3 timepoints (during surgery, 12-24 hours post-operative and 6 months post-operative)

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The BC Children's Hospital Orthopedic Clinic (Hip and Spine) will serve as the main recruitment site.

You may qualify if:

• 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;
• 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;
• between 5 and 18 years at the time of their surgical procedure

You may not qualify if:

• GMFCS level = I and CFCS level = I
• Non-English-speaking Parents/Caregivers
• Neurotypically developing children (GMFCS I and CFCS I) and;
• 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;
• Between 5 and 18 years of age at the time of their surgical procedure
• \) Non-English-speaking parents/caregivers

Sponsors & Collaborators

• University of British Columbia: lead
• BC Children's Hospital Research Institute: collaborator
• Canuck Place Children's Hospice Research Initiative: collaborator

Study Sites (1)

BC Children's Hospital Research Institute

Vancouver, British Columbia, V5Z 4H4, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The investigators will be collecting blood samples from study participants at 6 time points and control participants at 3 time points. A 3 mL aliquot of blood will be collected from participants, via venipuncture at timepoints 1, 3, 4, 5, and 6; and via peripheral line at timepoint 2 and 3 (when venipuncture is not conducted). Additionally, 50uL of blood will be collected from study participants through capillary sampling at timepoint 1. Following collection, the samples will be transferred to heparin-coated collection tubes, after which they will be transported to the BC Children's Hospital BioBank for storage.

MeSH Terms

Conditions

Neurologic Manifestations; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Inflammation; Pathologic Processes

Study Officials

• Hal Siden

  Department of Pediatrics, UBC

  PRINCIPAL INVESTIGATOR

• Liisa Holsti

  Department of Occupational Science and Occupational Therapy, UBC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Mette Hermansen

CONTACT

(604) 875 2000; ahermansen@bcchr.ca

Elaha Niazi

CONTACT

elaha.niazi@bcchr.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Hal Siden, MD, FRCPC

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 13, 2025
• Study Start: May 28, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)