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Trial registered on ANZCTR


Registration number
ACTRN12617000466347p
Ethics application status
Submitted, not yet approved
Date submitted
24/02/2017
Date registered
31/03/2017
Date last updated
31/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Monitoring for brain injury in infants undergoing cardiac surgery.
Scientific title
The Importance of Mean Arterial Blood Pressure in the Development of Brain Injury in Infants Undergoing Cardiac Surgery
Secondary ID [1] 291273 0
None
Universal Trial Number (UTN)
U1111-1191-8659
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
White matter brain injury 302212 0
Congenital heart disease 302468 0
Condition category
Condition code
Neurological 301816 301816 0 0
Other neurological disorders
Surgery 301817 301817 0 0
Other surgery
Cardiovascular 302030 302030 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Brain MRI before cardiac surgery and approximately 5-10 days after cardiac surgery depending on availability of MRI scanner and paediatric cardiac anaesthetist.

Arterial blood pressure will be monitored invasively with an invasive arterial line.
Intervention code [1] 297287 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301229 0
The total number and volume of new white matter lesions on post-operative MRI scanning.
Timepoint [1] 301229 0
Between 5-10 days post-operatively.
Primary outcome [2] 301230 0
The time spent below the lower limit of cerebral autoregulation.

This will be analysed by calculating the amount of time that is spent below the calculated lower limit of cerebral autoregulation for that child and comparing this to MRI brain findings. We will be doing this by correlating invasive arterial blood pressure to MRI findings.
Timepoint [2] 301230 0
During cardiac surgery and for 12 hours post-operatively
Primary outcome [3] 301452 0
The rate of new intracranial haemorrhage on brain MRI
Timepoint [3] 301452 0
A repeat MRI will be undertaken once between 5-10 days post operatively.
Secondary outcome [1] 332067 0
The rate of new stroke on post-operative brain MRI
Timepoint [1] 332067 0
Between 5-10 days post-operative.

Eligibility
Key inclusion criteria
Infants less than 4 weeks of age undergoing elective cardiac surgery with cardiopulmonary bypass at Starship Children's Hospital.
Minimum age
0 Weeks
Maximum age
4 Weeks
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Less than 36 weeks gestation
2. Multiple congenital abnormalities
3. Recognisable genetic or malformation syndrome associated with abnormal neurolodevelopment
4. History of maternal or congenital infection
5. History of birth asphyxia or cardiac arrest
6. A history of stroke or intracranial bleeding

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
A sample size of 75 patients was calculated for 80% power to detect a significance difference between the low MAP and not low MAP at alpha 0.05.

Analysis plan: the patient population will be described. 95% CI for proportions and means will be calculated and the low and not low mean BP groups will be compared using the Fisher's exact test, ANOVA or the Wilcoxon's rank sum test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8691 0
New Zealand
State/province [1] 8691 0
Auckland

Funding & Sponsors
Funding source category [1] 295728 0
Charities/Societies/Foundations
Name [1] 295728 0
Starship Foundation
Address [1] 295728 0
Starship Children's Hospital
Park Road
Grafton
Auckland 1023
Country [1] 295728 0
New Zealand
Primary sponsor type
Hospital
Name
Starship Children's Hospital
Address
Starship Children's Hospital
Park Road
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 294576 0
None
Name [1] 294576 0
Address [1] 294576 0
Country [1] 294576 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 297032 0
Health and Disability Ethics Committee
Ethics committee address [1] 297032 0
Ministry of Health
133 Molesworth Street
P.O.Box 5013
Wellington
6011
Ethics committee country [1] 297032 0
New Zealand
Date submitted for ethics approval [1] 297032 0
13/02/2017
Approval date [1] 297032 0
Ethics approval number [1] 297032 0

Summary
Brief summary
Sadly, children who undergo cardiac surgery as infants are at increased risk of learning difficulties as they grow older. Why this occurs is not known and white matter injury detected on specialised brain scans is considered to be the crucial link. This study will look at the relationship between blood pressure during, and after, cardiac surgery as the potential link. The study will also assess the critical blood pressure threshold to avoid injury as currently there is no published data to inform clinical practice.

The impact of this research: Preventing brain injury may not only improve neurodevelopmental outcomes in the growing population of ‘heart kids’ in New Zealand but also decrease the significant educational, economic and societal burden created by this potentially avoidable consequence of critical cardiac surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72770 0
Dr Anusha Ganeshalingham
Address 72770 0
Starship Children's Hospital
Paediatric Intensive Care Unit
Park Road
Auckland 1023
Country 72770 0
New Zealand
Phone 72770 0
+6421424504
Fax 72770 0
Email 72770 0
anushag@adhb.govt.nz
Contact person for public queries
Name 72771 0
Dr Anusha Ganeshalingham
Address 72771 0
Starship Children's Hospital
Paediatric Intensive Care Unit
Park Road
Auckland 1023
Country 72771 0
New Zealand
Phone 72771 0
+6421424504
Fax 72771 0
Email 72771 0
anushag@ahdb.govt.nz
Contact person for scientific queries
Name 72772 0
Dr Anusha Ganeshalingham
Address 72772 0
Starship Children's Hospital
Paediatric Intensive Care Unit
Park Road
Auckland 1023
Country 72772 0
New Zealand
Phone 72772 0
+6421424504
Fax 72772 0
Email 72772 0
anushag@adhb.govt.nz

No data has been provided for results reporting
Summary results
Not applicable