Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000454279
Ethics application status
Approved
Date submitted
14/03/2018
Date registered
28/03/2018
Date last updated
18/02/2020
Date data sharing statement initially provided
11/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Continuous Video EEG Monitoring in Acute Paediatric Ischaemic Stroke
Scientific title
Continuous Video EEG Monitoring in Acute Paediatric Ischaemic Stroke - describing Frequency and Predictors of subclinical and clinical Seizures
Secondary ID [1] 292862 0
none
Universal Trial Number (UTN)
U1111-1201-9550
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 304706 0
seizure 304707 0
ischemic stroke 307181 0
Condition category
Condition code
Neurological 304014 304014 0 0
Other neurological disorders
Stroke 306295 306295 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The cEEG will commence within 48 hours of study enrolment and within 10 days of stroke onset. The cEEG will be set-up by trained hospital neuroscientists, as per standard hospital procedure.
Duration of video EEG monitoring will be a minimum of 24hrs.

Acute neuroimaging will be reported as per current clinical practice. For study purposes, a second paediatric radiologist will review the original imaging (MRI, CT or ultrasound). This radiologist will be blinded to the occurrence of clinical or sub-clinical seizures. Neuroimaging analysis by the study radiologist will include infarct laterality (right, left, bilateral), location (anterior, middle, or posterior cerebral artery territories), tissue involved (cortex, white matter, basal ganglia), presence or absence of haemorrhage and vascular imaging analysis. Arterial occlusion will be defined as a hyperdense MCA sign on the initial CT scan or as an arterial “cutoff ” of on magnetic resonance angiography or computerized tomographic angiography. All electronically available scans will be further scored with the modified pediatric version of the Alberta Stroke Program Early Computed Tomography Score (modified PedASPECTS, range 0 to 30), a validated method for estimating infarct volume. Evidence of mass effect including sulcal effacement, ventricular compression, cistern effacement, midline shift, and herniation will also be documented.
Acute stroke severity will be assessed based the pedNIHSS (Pediatric National Institute of Health Stroke Scale) in accordance with the Australian Paediatric Stroke Guidelines (clinical practice recommendations). Other clinical scores will include the Functional status score and/or Modified Glascow outcome scale to assess function on discharge from PICU and/or hospital.
Demographic (age, gender, ethnicity), anthropometric data (height, weight, head circumference) and standard clinical data will also be collected, “Standard” clinical data includes medical history (including past medical history, history of presentation and family medical history), physical examination findings (including observations such as Glascow coma scale score, blood pressure, heart rate, pulse oximetry), investigation results (laboratory data, echocardiography and electrocardiography) and treatment provided. Clinical data will be obtained from the hospital electronic medical records. Investigations other than cEEG will be performed solely on a clinical basis.

Follow-up
Clinic visit assessments at 3, 6, 12, 18 and 24 months post stroke may include (some assessments will be age dependent):
- Standard clinical assessment (review of history, treatment, physical examination)
- Paediatric Stroke Outcome Measure (PSOM).10 This a validated tool to measure neurological outcome following stroke. It is based on a physical assessment performed by a clinician.
- Functional Status Score (FSS)
- Pediatric Cerebral Performance Category (PCPC) or Pediatric Overall Performance Category (POPC)
- Epilepsy/seizure questionnaire
A Neuropsychological assessment and parent questionnaires will be performed at 12 and 24 months post-stroke. The type of assessment or questionnaire will be made by the neuropsychologist (OL) as this will vary depending on the age of the patient and clinical symptoms.
Neuropsychological assessments may include:
- Wechsler Intelligence Scale for Children (WISC-V) – 7-16:11; Wechsler Primary and Preschool Scale of Intelligence (WPPSI-IV) 2.6-7; or Bayley scales of Infant Development (<4 years of age), dependent on age, to assess general intelligence
- Boston Naming Test (second Edition) – word finding
- NEPSY-II subtests - Design Memory (memory), Animal Sorting (EF), and Verbal Fluency (language)
- Rey Complex figure test (memory, EF)
- Children’s Memory Scale (CMS) – word pairs, story memory subtests (all memory)
- Continuous Performance Test (CPT3; attention) – Test of Everyday Attention for Children (TEA-Ch)
- Screening tests from the Wechsler Individual Achievement Test (WIAT-III) – reading, spelling, maths
- Clinical Evaluation of Language (CELF-5) to assess language
Parent Questionnaires may include:
- Behaviour Rating Inventory of Executive Functioning (BRIEF; covers EF)
- Conners Parent Rating Scale (Attention)
- Adaptive Behaviour Assessment System (ABAS-3)
- CBCL (Child behaviour checklist) or Strengths and Difficulties Questionnaire – mental health (CBCL is probably stronger here; a bit broader, but SDQ is popular at present).
- WeeFIM (interview)
- Background questionnaire (including but not limited to re pre-injury diagnoses, therapy inputs), and socioeconomic screen (based on occupation of primary caregiver or income)
- The family assessment Device (FAD) – general functioning scale re family functioning
- Family Burden or Injury Inventory – family burden
Intervention code [1] 299105 0
Not applicable
Comparator / control treatment
The control group will consist of patients admitted to our stroke service in the 2 years preceding the study intervention.
Control group
Historical

Outcomes
Primary outcome [1] 303347 0
seizure burden (percentage of every hour of EEG occupied by electrographic or clinical seizures)
assessed via EEG review/EEG records
Timepoint [1] 303347 0
within 30 days of acute stroke
Primary outcome [2] 305348 0
percentage of patients with seizures - subclinical and/or clinical
assessed via clinical records/hospital records and at patient follow up (questionnaire)
Timepoint [2] 305348 0
30 days following stroke
Secondary outcome [1] 338728 0
Paediatric Intensive Care Unit (PICU) and/or hospital length of stay - as assessed by data linkage to medical records
Timepoint [1] 338728 0
within first year from acute stroke
Secondary outcome [2] 338729 0
mortality -
as assessed by data linkage to medical records
Timepoint [2] 338729 0
within 2 years from acute stroke
Secondary outcome [3] 338730 0
neurological outcome - assessed by Paediatric Stroke Outcome Measure (PSOM) and other standardized speech and language and cognitive assessments
Timepoint [3] 338730 0
within first 2 years following acute stroke and at 5 and 10 years following stroke
Secondary outcome [4] 338731 0
development of epilepsy (as defined as one unprovoked clinical seizure more then 6 weeks following the acute stroke)
assessed via review of medical records and patient report
Timepoint [4] 338731 0
within the first 2 years following stroke and at 5 and 10 years following the acute stroke

Eligibility
Key inclusion criteria
infants and children diagnosed with acute arterial ischaemic stroke who meet the following inclusion criteria:

Age:
Children and infants >28 days and < 18 yrs of age
infants <29 days of age will only be included if admitted to the PICU

The stroke will have occurred within 10 days prior to commencement of video EEG monitoring
Ischaemic stroke sub-types include arterial and venous.
Background information for all children presenting with AIS will be collected even if cEEG monitoring is not indicated.
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with haemorrhagic stroke and solely hypoperfusion related brain ischaemia will be excluded

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Exploratory data analysis will initially be undertaken and reported. Continuous variables will be described by means/standard deviations if normally distributed and by medians/interquartile ranges if otherwise. Categorical variables will be described as frequencies and percentages. One sample t-tests and Wilcoxon one-sample signed rank tests will be used to compare patients’ neuropsychological profiles with those of the normative sample. In order handle the longitudinal nature of the data, generalised estimating equations (GEEs) will used to analyse outcome measures. Link functions will vary according to variable type: identity for continuous (e.g. hospital length of stay), logit for binary (e.g. mortality) and negative binomial for count (e.g. epilepsy occurrence). Model diagnostics will include the visual examination of the raw and standardized residuals. Residuals will be plotted against predicted values of each observation, and the normality of the residual assessed by the Wilk-Shapiro test. In addition, the Quasi-likelihood information criterion (QIC) will be used to assess model fit given the non-likelihood based nature of GEEs. For all statistical testing, the level of significance will be set at 5% and two-sided tests will be used. SPSS version 18.0 software will be used for all statistical analyses.
Variables to be analysed will include:
• Age at time of stroke and gender
• Stroke aetiology
• PedNIHSS/ stroke severity
• Modified pediatric ASPECTS score
• Stroke location on neuroimaging
• Presence of acute clinical, subtle or sub-clinical seizures
• Acute seizure burden
• Co-morbidities
• Stroke recurrence
• Occurrence of remote seizures and epilepsy, seizure frequency and treatment
• Paediatric Stroke Outcome Measure (PSOM)
• Results of neuropsychological outcome assessments and questionnaires
• PICU admission and length of stay
• Hospital length of stay
• Mortality
• Functional Status Score (FSS), Pediatric Cerebral Performance Category (PCPC) and Pediatric Overall Performance Category (POPC)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2018
Actual
1/07/2018
Date of last participant enrolment
Anticipated
1/07/2020
Actual
Date of last data collection
Anticipated
1/03/2030
Actual
Sample size
Target
60
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8991 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [2] 13360 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 17492 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 297492 0
Government body
Name [1] 297492 0
Queensland government
Country [1] 297492 0
Australia
Primary sponsor type
Individual
Name
Michaela Waak
Address
Main Hospital Building Level 7, 7d
Lady CIlento CHildrens Hospital
501 Stanley street
south Brisbane, QLD 4101
Country
Australia
Secondary sponsor category [1] 296503 0
None
Name [1] 296503 0
Address [1] 296503 0
Country [1] 296503 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298592 0
Children’s Health Queensland Human Research Ethics Committee [EC00175]
Ethics committee address [1] 298592 0
Level 7, Centre for Children’s Health Research
Lady Cilento Children’s Hospital Precinct, South Brisbane QLD 4101
Ethics committee country [1] 298592 0
Australia
Date submitted for ethics approval [1] 298592 0
12/03/2018
Approval date [1] 298592 0
10/05/2018
Ethics approval number [1] 298592 0
HREC/18/QRCH/81

Summary
Brief summary
There is a retrospective and prospective component to the study. Retrospective patients will be identified through the LCCH clinical stroke database, the Paediatric Intensive Care Unit database and a hospital ICD code search.
Appropriate data will be collected and interpreted retrospectively. No additional Video-EEg monitoring will occur. The patients will be followed (neurovascular outpatient clinic and the Queensland Paediatric Rehabilitation Service). This will mainly include standard outpatient appointments. Outcome measures will include the Paediatric Stroke Outcome Measure (PSOM), development of epilepsy and standardized speech and language and cognitive assessments. Outcome will also be comparative to allow for possible baseline developmental delay.
Prospective patients will be notified to the study team by neurology, neurosurgery, the emergency department or the paediatric intensive care unit. Study duration will be 2 years. Retrospective patients will be identified from the 2 years preceding the study start date. Follow up is planned for the usual stroke clinic care and for 5 and 10 years.
For prospective patients, Video EEG monitoring will occur alongside standard paediatric stroke care. Stroke management will be based on the Australian Paediatric Stroke Guidelines (currently in draft format). Duration of video EEG monitoring will be a minimum of 24hrs. Standardised data will also be collected on all patients with ischaemic stroke over the 2-year study period.
The treating clinician will use their discretion to delay or remove the video EEG monitoring if it impedes standard clinical care. The decision whether or not to treat sub-clinical and clinical seizures is at the discretion of the treating clinician however guidance is provided in the Australian Paediatric Stroke Guidelines.
Acute neuroimaging (MRI brain) will be reported as per current clinical practice. For study purposes, a second paediatric radiologist will review the imaging. This radiologist will be blinded to the occurrence of clinical or sub-clinical seizures. Neuroimaging analysis will include stroke type and location, presence or absence of haemorrhage and vascular imaging analysis. Where possible volumetric analysis will be performed.
Stroke severity will be assessed based the pedNIHSS (Pediatric National Institute of Health Stroke Scale) in concordance with the Australian Paediatric Stroke Guidelines. For the retrospective component of the study the PedNIHSS will be applied retrospectively.
Follow-up (outpatient clinic setting) will occur through the neurovascular outpatient clinic and the Queensland Paediatric Rehabilitation Service. Outcome measures will include the Paediatric Stroke Outcome Measure (PSOM), development of epilepsy and standardized speech and language and cognitive assessments.
Patients will be treated as per usual standard of care and the only difference for prospective patients will be the duration of the Video-EEG monitoring.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77590 0
Dr Michaela Waak
Address 77590 0
Main Hospital building, Level 7, 7d
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane, Qld 4101
Country 77590 0
Australia
Phone 77590 0
+61 7 30681111
Fax 77590 0
Email 77590 0
Michaela.Waak@health.qld.gov.au
Contact person for public queries
Name 77591 0
Dr Michaela Waak
Address 77591 0
Main Hospital building, Level 7, 7d
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane, Qld 4101
Country 77591 0
Australia
Phone 77591 0
+61 7 30681111
Fax 77591 0
Email 77591 0
Michaela.Waak@health.qld.gov.au
Contact person for scientific queries
Name 77592 0
Dr Michaela Waak
Address 77592 0
Main Hospital building, Level 7, 7d
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane, Qld 4101
Country 77592 0
Australia
Phone 77592 0
+61 7 30681111
Fax 77592 0
Email 77592 0
Michaela.Waak@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
redcap database data only


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.