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Post-operative Changes Study

NCT07121660 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 17

Last updated 2025-08-13

No results posted yet for this study

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.

Conditions

  • Post-operative Functional Decline
  • Severe Neurological Impairment

Sponsors & Collaborators

  • BC Children's Hospital Research Institute

    collaborator OTHER

  • Canuck Place Children's Hospice Research Initiative

    collaborator UNKNOWN

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Hal Siden · Department of Pediatrics, UBC

  • Liisa Holsti · Department of Occupational Science and Occupational Therapy, UBC

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-28
Primary Completion
2026-01-31
Completion
2027-05-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07121660 on ClinicalTrials.gov