Actively Recruiting

Age: 5Years - 18Years
All Genders
NCT07121660

Post-operative Changes Study

Led by University of British Columbia · Updated on 2025-08-13

17

Participants Needed

1

Research Sites

100 weeks

Total Duration

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Sponsors

U

University of British Columbia

Lead Sponsor

B

BC Children's Hospital Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Post-operative Changes Study

Who Can Participate

Age: 5Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children with severe neurological impairment (GMFCS levels II-V and CFCS levels II-V)
  • Undergoing major orthopedic surgery (spine or hip) lasting more than 90 minutes at BC Children's Hospital
  • Between 5 and 18 years old at the time of surgery
  • Neurotypically developing children (GMFCS I and CFCS I) undergoing major orthopedic surgery at the same hospital
  • Between 5 and 18 years old at the time of surgery for control group
Not Eligible

You will not qualify if you...

  • Children with GMFCS level I and CFCS level I
  • Parents or caregivers who do not speak English

AI-Screening

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Trial Site Locations

Total: 1 location

1

BC Children's Hospital Research Institute

Vancouver, British Columbia, Canada, V5Z 4H4

Actively Recruiting

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Research Team

A

Anne-Mette Hermansen

CONTACT

E

Elaha Niazi

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Post-operative Changes Study | DecenTrialz