Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001580763
Ethics application status
Approved
Date submitted
2/12/2022
Date registered
21/12/2022
Date last updated
10/12/2023
Date data sharing statement initially provided
21/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Measuring recovery after scoliosis surgery
Scientific title
Neurocognitive trajectory in adolescents recovering from major spinal surgery for idiopathic scoliosis
Secondary ID [1] 308541 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Neurotraject
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Decreased neurocognition post-surgery 328385 0
Anaesthesia-related side effects 328386 0
Spinal surgery 328387 0
surgery 328388 0
Condition category
Condition code
Anaesthesiology 325414 325414 0 0
Anaesthetics
Surgery 325415 325415 0 0
Other surgery
Mental Health 325416 325416 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The trajectory of the child’s neurocognitive function will be assessed using psychometric testing at regular intervals; baseline, 2 weeks post-operatively, 6 weeks post-operatively and 6 months post-operatively.
Participants will receive the scoliosis surgery regardless of their participating in the study.
The neurocognitive testing will seated computer-based tasks as well as completion of questionnaires and tests. The total testing time for the study is expected to be about 3-4 hours.
Participants will be required to provide 4 blood samples for biomarker analysis.
Assessments will be conducted both face-to-face at the hospital and online.
Testing sessions will be supervised by the study psychologist.
Intervention code [1] 324988 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333279 0
Computerized Neurocognitive Screening (CNS)-Vital Neurocognitive score
Timepoint [1] 333279 0
Baseline, 2 weeks, 6 weeks (primary timepoint) and 6 months after surgery
Secondary outcome [1] 416435 0
CNS: Complex attention

We are administering the computerised neuropsychological test battery CNS-Vital Signs (https://www.cnsvs.com/) to assess each of these domains. We have chosen this battery of computerised subtests over traditional pen and paper assessments because of its ability to provide alternative forms to minimise practice effects and that reaction time can be collected to the millisecond. It also allows for remote testing via telehealth enabling us to engage a greater number of participants.
Timepoint [1] 416435 0
Baseline, 2 weeks, 6 weeks and 6 months after surgery
Secondary outcome [2] 416436 0
CNS: Cognitive flexibility

We are administering the computerised neuropsychological test battery CNS-Vital Signs (https://www.cnsvs.com/) to assess each of these domains. We have chosen this battery of computerised subtests over traditional pen and paper assessments because of its ability to provide alternative forms to minimise practice effects and that reaction time can be collected to the millisecond. It also allows for remote testing via telehealth enabling us to engage a greater number of participants.
Timepoint [2] 416436 0
Baseline, 2 weeks, 6 weeks and 6 months after surgery
Secondary outcome [3] 416437 0
CNS: Composite memory

We are administering the computerised neuropsychological test battery CNS-Vital Signs (https://www.cnsvs.com/) to assess each of these domains. We have chosen this battery of computerised subtests over traditional pen and paper assessments because of its ability to provide alternative forms to minimise practice effects and that reaction time can be collected to the millisecond. It also allows for remote testing via telehealth enabling us to engage a greater number of participants.
Timepoint [3] 416437 0
Baseline, 2 weeks, 6 weeks and 6 months after surgery
Secondary outcome [4] 416438 0
California Verbal Learning Test
Timepoint [4] 416438 0
Baseline, 6 weeks and 6 months after surgery
Secondary outcome [5] 416439 0
CNS: Visual Memory

We are administering the computerised neuropsychological test battery CNS-Vital Signs (https://www.cnsvs.com/) to assess each of these domains. We have chosen this battery of computerised subtests over traditional pen and paper assessments because of its ability to provide alternative forms to minimise practice effects and that reaction time can be collected to the millisecond. It also allows for remote testing via telehealth enabling us to engage a greater number of participants.
Timepoint [5] 416439 0
Baseline, 2 weeks, 6 weeks and 6 months after surgery
Secondary outcome [6] 416440 0
Strengths and Difficulties Questionnaire
Timepoint [6] 416440 0
Baseline, 2 weeks, 6 weeks and 6 months after surgery
Secondary outcome [7] 416441 0
PROMIS Anxiety
Timepoint [7] 416441 0
Baseline, 2 weeks, 6 weeks and 6 months after surgery
Secondary outcome [8] 416442 0
PROMIS Depression
Timepoint [8] 416442 0
Baseline, 2 weeks, 6 weeks and 6 months after surgery
Secondary outcome [9] 416443 0
PedsQL Fatigue Scale
Timepoint [9] 416443 0
Baseline, 2 weeks, 6 weeks and 6 months after surgery
Secondary outcome [10] 416444 0
Scoliosis Research Society (SRS-22r) patient survey to assess quality of life
Timepoint [10] 416444 0
Baseline, 2 weeks, 6 weeks and 6 months after surgery
Secondary outcome [11] 416445 0
Cornell Assessment of Pediatric Delirium
Timepoint [11] 416445 0
Twice a day up until 96 hours after surgery or until delirium has resolved
Secondary outcome [12] 416446 0
Biomarker analysis of serum samples

Specific biomarkers: neurofilament light chain (NFL), Glial Fibrillary acidic protein (GFAP), tau
Timepoint [12] 416446 0
Start of surgery (baseline), completion of surgery, 12 hours post-surgery, and 48 hours post-surgery.

Eligibility
Key inclusion criteria
A child scheduled to undergo idiopathic scoliosis surgery whose age at scheduled time of surgery is between the ages of 10 and 16 years.
Minimum age
10 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Known neurologic, neurodevelopmental, or behavioural diagnoses which are likely to be associated with poor neurobehavioural outcome,
• Socio-demographic circumstances where follow up is likely to be difficult and
• Living in a household where the primary language spoken at home is not a language in which we can administer the CNS-Vital Neurocognitive score.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
For the purpose of sample size estimation, the primary outcome to consider will be performance on the Neurocognitive Index, with a mean of 100 and an SD of 15. A priori power analysis using G*Power 3.1 estimated a required sample between 40 and 98 participants based on the Neurocognitive Index as the outcome measure. (ANOVA: repeated measures between factors, p = .05, power= .8, estimated effect size f 0.4; large and 0.25; medium).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/12/2023
Actual
Date of last participant enrolment
Anticipated
1/02/2025
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 23667 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [2] 23668 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 39094 0
2145 - Westmead
Recruitment postcode(s) [2] 39093 0
3052 - Parkville
Recruitment outside Australia
Country [1] 25164 0
Switzerland
State/province [1] 25164 0
Geneva

Funding & Sponsors
Funding source category [1] 312789 0
Charities/Societies/Foundations
Name [1] 312789 0
Australian and New Zealand College of Anaesthetists
Country [1] 312789 0
Australia
Funding source category [2] 312790 0
Charities/Societies/Foundations
Name [2] 312790 0
Society of Paediatric Anaesthesia in New Zealand and Australia
Country [2] 312790 0
Australia
Primary sponsor type
Other
Name
Murdoch Children's Research Institute
Address
Royal Children's Hospital
Flemington Road
Parkville VIC 3052 Australia
Country
Australia
Secondary sponsor category [1] 314422 0
None
Name [1] 314422 0
Address [1] 314422 0
Country [1] 314422 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312078 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 312078 0
Royal Children's Hospital
Flemington Road
Parkville
VIC 3052 Australia
Ethics committee country [1] 312078 0
Australia
Date submitted for ethics approval [1] 312078 0
28/11/2022
Approval date [1] 312078 0
01/02/2023
Ethics approval number [1] 312078 0
89229

Summary
Brief summary
This is an international study that aims to determine if there is a decline in neurocognitive function in children having scoliosis surgery.
The trajectory of the child’s neurocognitive function will be assessed using well validated
psychometric testing at regular intervals; baseline, 2 weeks post-operatively, 6 weeks post-operatively and 6 months post-operatively. The following aspects of neurocognition will be assessed: reaction time, attention, inhibition, and memory including working memory. The incidence and time course of post-operative delirium will be assessed in the first 48 hours or until discharge after surgery. Blood will be sampled for biomarkers during the immediate peri-operative period, for future analysis.

We aim to enroll 50 children aged between 10 and 16 years.
Currently we have no data on which to base recommendations for when children should return to school, what to expect in terms of functioning at school or when to sit exams after surgery. This study targets what could plausibly be a high risk group – major surgery. The findings from this study should have an immediate impact on what we tell parents as well as being an example for similar studies for other surgeries. The study will also provide data to understand aetiology, potential risk groups and possible targets for future interventions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123390 0
Prof Andrew Davidson
Address 123390 0
Department of Anaesthesia
Royal Children's Hospital
50 Flemington Road, Parkville, Victoria, 3052
Country 123390 0
Australia
Phone 123390 0
+61 393455233
Fax 123390 0
Email 123390 0
andrew.davidson@rch.org.au
Contact person for public queries
Name 123391 0
Ms Suzette Sheppard
Address 123391 0
Department of Anaesthesia
Royal Children's Hospital
50 Flemington Road, Parkville, Victoria, 3052
Country 123391 0
Australia
Phone 123391 0
+61 393455233
Fax 123391 0
Email 123391 0
suzette.sheppard@mcri.edu.au
Contact person for scientific queries
Name 123392 0
Prof Andrew Davidson
Address 123392 0
Department of Anaesthesia
Royal Children's Hospital
50 Flemington Road, Parkville, Victoria, 3052
Country 123392 0
Australia
Phone 123392 0
+61 393455233
Fax 123392 0
Email 123392 0
andrew.davidson@rch.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
One year after publication of the primary outcome paper; no end date determined.
Available to whom?
Before data are shared, the study investigators will assess the scientific merit of the project requesting the data and ensure all ethical, regulatory and data transfer agreements are in order.
Available for what types of analyses?
Any purpose as long as the the scientific merit of the project is sound.
How or where can data be obtained?
By applying for access to the study principal investigators via email:

andrew.davidson@rch.org.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17774Study protocol  andrew.davidson@rch.org.au
17775Statistical analysis plan  andrew.davidson@rch.org.au
17776Informed consent form  andrew.davidson@rch.org.au
17777Ethical approval  andrew.davidson@rch.org.au
17778Analytic code  andrew.davidson@rch.org.au



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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