Post-operative Changes Study

University of British Columbia17 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Post-operative Functional Decline Severe Neurological Impairment

Eligibility

Sex: ALLMin age: 5 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

To evaluate the feasibility of the study protocol for children and their families living with severe neurological impairment.

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).

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.

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.

Time frame: From enrollment to the end-of-study interview approximately 6 months after surgery.

Secondary Outcomes

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.

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.

Time frame: From enrollment to 6 months following surgery.

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.

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.