Post-operative Changes Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Post-operative Functional Decline, Severe Neurological Impairment. Basic parameters: 5 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Post-operative Changes in Children With Severe Neurological Impairment
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.
Primary outcome measures
- 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.]
Secondary outcome measures (2)
- 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. [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. [Time frame: From enrollment to 6 months following surgery.]
Eligibility criteria
Inclusion Criteria for Study Participants
- 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;
- 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;
- between 5 and 18 years at the time of their surgical procedure
Exclusion Criteria for Study Participants:
- GMFCS level = I and CFCS level = I
- Non-English-speaking Parents/Caregivers
Inclusion Criteria for Control Group Participants:
- Neurotypically developing children (GMFCS I and CFCS I) and;
- 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;
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- BC Children's Hospital Research Institute — Vancouver
Identifiers
NCT: NCT07121660 · H24-01880