Post-operative Functional DeclineNCT07121660
Post-operative Changes Study
An observational study of Post-operative Functional Decline and Severe Neurological Impairment, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Post-operative Functional Decline, Severe Neurological Impairment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- 28 May 2025to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The BC Children's Hospital Orthopedic Clinic (Hip and Spine) will serve as the main recruitment site.
Who may be able to join
- 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
- 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
Who cannot join
- GMFCS level = I and CFCS level = I
- Non-English-speaking Parents/Caregivers
- 1) Non-English-speaking parents/caregivers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elaha Niazi contact
Canada1 site, 1 recruiting
- Recruiting
BC Children's Hospital Research Institute
Vancouver, British Columbia, V5Z 4H4
Anne-Mette Hermansen, (604) 875 2000 ext. 6909, ahermansen@bcchr.ca
About this study
Official title: Post-operative Changes in Children With Severe Neurological Impairment
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.
- Keywords
- Severe Neurological Impairment, Post-operative functional decline, Neuroinflammation
- Medical subject headings
- Neurologic Manifestations, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Participants | The study participants are the children with severe neurological impairment (SNI) undergoing major (>90 minute procedure) orthopedic surgery to manage musculoskeletal pathology between the ages of 5 and 18 at the time of surgery and their parent/caregiver. Blood will be collected from the child with SNI (at 6 different time points: at the pre-operative assessment, at the time of surgery, 12-24 hours post-operative, 1-2 weeks post-operative, 6 weeks post-operative and 6 months post-operative). The parent/caregiver of the child will be completing the Caregivers Priorities and Child Health Index of Life with Disabilities (CPCHILD) Questionnaire and answer two supplemental questions (at the pre-operative visit, at a 6-weeks post-operative visit and a 6-month post-operative visit). At the initial pre-operative study visit, the parent/caregiver will also complete a demographics form in which demographic information of the child and the parent/caregiver will be collected. | |
| Control Participants | The control participants group will consist of neurotypically developing children undergoing spine surgery for scoliosis between the ages of 5 and 18 at the time of their surgical procedure. The child or the parent/caregiver of the child, depending on the age of the child, will complete a demographic form and then have blood samples collected at 3 timepoints (during surgery, 12-24 hours post-operative and 6 months post-operative) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: From enrollment to the end-of-study interview approximately 6 months after surgery.
Secondary outcomes (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.
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.
Measured: 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.
Measured: From enrollment to 6 months following surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start28 May 2025
- Primary completionJan 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative Functional DeclineStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- BC Children's Hospital Research Institute, Canuck Place Children's Hospice Research Initiative
- Responsible party
- Principal investigator, Harold Siden, University of British Columbia
- Investigators
- Hal Siden, Principal investigator, Department of Pediatrics, UBCLiisa Holsti, Principal investigator, Department of Occupational Science and Occupational Therapy, UBC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121660
- Sponsor's protocol ID
- H24-01880
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In this small study patient deidentification is a priority and IPD may be a problem for confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Changes in Children With Severe Neurological Impairment
- ClinicalTrials.gov ID
- NCT07121660
- Acronym / sponsor ID
- H24-01880
- Keywords
- Severe Neurological Impairment, Post-operative functional decline, Neuroinflammation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- BC Children's Hospital Research Institute, Canuck Place Children's Hospice Research Initiative
- Study start
- 28 May 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Participants | – | –The study participants are the children with severe neurological impairment (SNI) undergoing major (>90 minute procedure) orthopedic surgery to manage musculoskeletal pathology between the ages of 5 and 18 at the time of surgery and their parent/caregiver. Blood will be collected from the child with SNI (at 6 different time points: at the pre-operative assessment, at the time of surgery, 12-24 hours post-operative, 1-2 weeks post-operative, 6 weeks post-operative and 6 months post-operative). The parent/caregiver of the child will be completing the Caregivers Priorities and Child Health Index of Life with Disabilities (CPCHILD) Questionnaire and answer two supplemental questions (at the pre-operative visit, at a 6-weeks post-operative visit and a 6-month post-operative visit). At the initial pre-operative study visit, the parent/caregiver will also complete a demographics form in which demographic information of the child and the parent/caregiver will be collected. |
| Control Participants | – | –The control participants group will consist of neurotypically developing children undergoing spine surgery for scoliosis between the ages of 5 and 18 at the time of their surgical procedure. The child or the parent/caregiver of the child, depending on the age of the child, will complete a demographic form and then have blood samples collected at 3 timepoints (during surgery, 12-24 hours post-operative and 6 months post-operative) |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The BC Children's Hospital Orthopedic Clinic (Hip and Spine) will serve as the main recruitment site.
Key inclusion criteria (6 listed)
- 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
- 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;
Key exclusion criteria (3 listed)
- GMFCS level = I and CFCS level = I
- Non-English-speaking Parents/Caregivers
- 1) Non-English-speaking parents/caregivers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Time frame: 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.
2 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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No. In this small study patient deidentification is a priority and IPD may be a problem for confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elaha Niazi contact
Hal Siden principal investigator
Department of Pediatrics, UBC
Liisa Holsti principal investigator
Department of Occupational Science and Occupational Therapy, UBC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-operative Functional Decline and Severe Neurological Impairment, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne-Mette Hermansen ((604) 875 2000 ext. 6909, ahermansen@bcchr.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.