Post-operative Changes Study

NCT ID: NCT07121660

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-28
• Study Completion Date: 2027-05-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

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

1. GMFCS level = I and CFCS level = I

2. Non-English-speaking Parents/Caregivers

1) Non-English-speaking parents/caregivers

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BC Children's Hospital Research Institute

OTHER

Sponsor Role: collaborator

Canuck Place Children's Hospice Research Initiative

UNKNOWN

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Harold Siden

Dr. Hal Siden, MD, FRCPC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hal Siden

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics, UBC

Liisa Holsti

Role: PRINCIPAL_INVESTIGATOR

Department of Occupational Science and Occupational Therapy, UBC

Locations

BC Children's Hospital Research Institute

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Anne-Mette Hermansen

Role: CONTACT

ahermansen@bcchr.ca

(604) 875 2000 ext. 6909

Elaha Niazi

Role: CONTACT

elaha.niazi@bcchr.ca

Facility Contacts

Anne-Mette Hermansen

Role: primary

ahermansen@bcchr.ca

(604) 875 2000 ext. 6909

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

H24-01880

Identifier Type: -

Identifier Source: org_study_id