Post-operative Changes Study

Recruiting

• Conditions: Post-operative Functional Decline; Severe Neurological Impairment

• Registration Number: NCT07121660
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-28
• Study First Submitted: 2025-07-30
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-06
• Last Update Submitted: 2025-08-06
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Primary Completion: 2026-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the feasibility of the study protocol for children and their families living with severe neurological impairment.	From enrollment to the end-of-study interview approximately 6 months after surgery.	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).
To evaluate the acceptability of the study protocol for children and their families living with severe neurological impairment.	From enrollment to the end-of-study interview approximately 6 months after surgery.	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.

Secondary Outcome Measures

Name	Time	Method
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.	The functional changes of children with SNI over the perioperative period will be assessed using the Caregivers Priorities and Child Health Index of Life with Disabilities (CPCHILD) Questionnaire. The CPCHILD Questionnaire is used to assess the effectiveness of interventions aimed at improving and preserving outcomes for children aged 5-18 years of age with severe disabilities, based on caregivers' perspectives and thus, can be used to track functional changes of children over time. Parents/caregivers will also be asked a supplemental question to provide further insight into other areas of function that were not described by CPCHILD.
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.	This objective will also be assessed using the Caregivers Priorities and Child Health Index of Life with Disabilities (CPCHILD) Questionnaire. The CPCHILD Questionnaire is used to assess the effectiveness of interventions aimed at improving and preserving outcomes for children aged 5-18 years of age with severe disabilities, based on caregivers' perspectives. Within the CPCHILD parents/caregivers are asked questions about their child's quality of life and parents/caregivers will also be asked to answer a supplemental question to provide further insight into the quality of life of caregivers.

Trial Locations

Locations (1)

BC Children's Hospital Research Institute; 🇨🇦 Vancouver, British Columbia, Canada