Clinical Trial

Post-operative Changes Study

Recruiting
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Record status
This record was last updated August 13, 2025 (before its estimated January 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07121660
Lead Sponsor University of British Columbia
Collaborators: BC Children's Hospital Research Institute, Canuck Place Children's Hospice Research Initiative
Conditions Post-operative Functional Decline, Severe Neurological Impairment
Enrollment 17 participants
Start Date 2025-05-28
Primary Completion 2026-01 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2025-08-13