Post-operative Changes Study

Condition(s) studied

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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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