Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT07121660

Conditions

Post-operative Functional Decline

Severe Neurological Impairment

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

Study Details

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 ID

NCT07121660

Start date

May 28, 2025

Status verified date

Aug, 2025

Completion date

May, 2027

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

17 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

Primary outcome measure

  • To evaluate the feasibility of the study protocol for children and their families living with severe neurological impairment. [ Time Frame: 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. [ Time Frame: From enrollment to the end-of-study interview approximately 6 months after surgery. ]

Central Contacts and Locations

Central contacts

Anne-Mette Hermansen

(604) 875 2000ahermansen@bcchr.ca

Elaha Niazi

elaha.niazi@bcchr.ca

Locations

BC Children's Hospital Research Institute

Recruiting

Vancouver, British Columbia, Canada, V5Z 4H4

Contacts

Anne-Mette Hermansen

(604) 875 2000ahermansen@bcchr.ca

More Information

Sponsor

University of British Columbia

Last update posted

Aug 13, 2025

Last verified

Aug, 2025

Keywords

  • Severe Neurological Impairment
  • Post-operative functional decline
  • Neuroinflammation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2025-08-13.