Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000089235
Ethics application status
Approved
Date submitted
9/12/2017
Date registered
19/01/2018
Date last updated
24/06/2021
Date data sharing statement initially provided
20/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of nitric oxide administration during cardiopulmonary bypass in neonates undergoing Arterial Switch Operation for repair of transposition of the great arteries.
Scientific title
A randomised controlled trial of nitric oxide administration during cardiopulmonary bypass in neonates undergoing Arterial Switch Operation for repair of transposition of the great arteries to evaluate an effect on major adverse events (death, ECMO, cardiac arrest)
Secondary ID [1] 293572 0
Clinicaltrials.gov trial number: NCT03661385
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
congenital heart disease 305809 0
transposition of the great arteries 305810 0
Condition category
Condition code
Surgery 305027 305027 0 0
Other surgery
Cardiovascular 305109 305109 0 0
Other cardiovascular diseases
Reproductive Health and Childbirth 305110 305110 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Addition of 20 parts per million nitric oxide to the oxygenator of the cardiopulmonary bypass circuit for the duration of bypass
Intervention code [1] 299822 0
Treatment: Other
Comparator / control treatment
Standard cardiopulmonary bypass
Control group
Active

Outcomes
Primary outcome [1] 304191 0
Composite primary outcome: Incidence of post-operative: cardiac arrest, delayed sternal closure, need for extracorporeal membranous oxygenation (ECMO), or death.
Timepoint [1] 304191 0
Hospital discharge
Secondary outcome [1] 341179 0
Length of stay in ICU as assessed from review of the medical records
Timepoint [1] 341179 0
date of discharge from PICU
Secondary outcome [2] 341471 0
length of hospital stay as assessed from review of the medical records
Timepoint [2] 341471 0
hospital discharge date
Secondary outcome [3] 341472 0
ventilator free days as assessed from review of the medical records
Timepoint [3] 341472 0
date of discharge from PICU
Secondary outcome [4] 341473 0
inotrope free days as assessed from review of the medical records
Timepoint [4] 341473 0
date of discharge from PICU
Secondary outcome [5] 341474 0
nitric oxide free days as assessed from review of the medical records
Timepoint [5] 341474 0
date of discharge from PICU
Secondary outcome [6] 341475 0
dialysis free days as assessed from review of the medical records
Timepoint [6] 341475 0
date of discharge from PICU
Secondary outcome [7] 341476 0
ECMO free days as assessed from review of the medical records
Timepoint [7] 341476 0
date of discharge from PICU
Secondary outcome [8] 341477 0
days with open sternum as assessed from review of the medical records
Timepoint [8] 341477 0
date of discharge from PICU

Eligibility
Key inclusion criteria
• Neonate diagnosed with TGA requiring Arterial Switch Operation
• Consent of parents/guardian.
Minimum age
No limit
Maximum age
1 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Signs of persistently elevated pulmonary vascular resistance preoperatively requiring iNO or preoperative use of drugs involved in the NO pathway, such as nitro-glycerine, sildenafil
• Requirement for ECLS prior to surgery
• Concurrent viral or bacterial acute or chronic infection, including pulmonary conditions such as pneumonia
• Pre-operative acute respiratory distress syndrome
• Cardiac arrest prior to surgery
• Prior surgical exposure to cardio-pulmonary bypass

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2018
Actual
25/05/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 9517 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [2] 9518 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [3] 9519 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [4] 9520 0
Princess Margaret Hospital - Subiaco
Recruitment postcode(s) [1] 18266 0
3052 - Parkville
Recruitment postcode(s) [2] 18267 0
4101 - South Brisbane
Recruitment postcode(s) [3] 18268 0
2145 - Westmead
Recruitment postcode(s) [4] 18269 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 9416 0
New Zealand
State/province [1] 9416 0
Country [2] 9417 0
United Kingdom
State/province [2] 9417 0
Country [3] 9418 0
United States of America
State/province [3] 9418 0
Country [4] 9419 0
Italy
State/province [4] 9419 0
Country [5] 9420 0
Germany
State/province [5] 9420 0
Country [6] 9421 0
Netherlands
State/province [6] 9421 0
Country [7] 9422 0
Canada
State/province [7] 9422 0
Country [8] 21188 0
Israel
State/province [8] 21188 0
Country [9] 21189 0
Thailand
State/province [9] 21189 0
Country [10] 21190 0
Malaysia
State/province [10] 21190 0
Country [11] 21191 0
Indonesia
State/province [11] 21191 0

Funding & Sponsors
Funding source category [1] 298184 0
Hospital
Name [1] 298184 0
in-kind support from Royal Children's Hospital Department of Paediatric Intensive Care Flemington Road Parkville Melbourne VIC 3052
Country [1] 298184 0
Australia
Primary sponsor type
Individual
Name
Christopher James
Address
PICU
Royal Children's Hospital
Parkville
Melbourne
VIC 3052
Country
Australia
Secondary sponsor category [1] 297374 0
None
Name [1] 297374 0
Address [1] 297374 0
Country [1] 297374 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299198 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 299198 0
50 Flemington Road , Parkville, VIC 3052
Ethics committee country [1] 299198 0
Australia
Date submitted for ethics approval [1] 299198 0
11/12/2017
Approval date [1] 299198 0
24/05/2018
Ethics approval number [1] 299198 0
38017

Summary
Brief summary
To test the hypothesis that addition of nitric oxide, a gas with anti-inflammatory properties, to the CPB circuit could improve post-operative outcome for children with transposition of the great arteries undergoing the arterial switch operation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79626 0
Dr Christopher James
Address 79626 0
PICU
Royal Children's Hospital
Flemington Road
Parkville
VIC 3052
Country 79626 0
Australia
Phone 79626 0
+61451955050
Fax 79626 0
Email 79626 0
[email protected]
Contact person for public queries
Name 79627 0
Christopher James
Address 79627 0
PICU
Royal Children's Hospital
Flemington Road
Parkville
VIC 3052
Country 79627 0
Australia
Phone 79627 0
+61451955050
Fax 79627 0
Email 79627 0
[email protected]
Contact person for scientific queries
Name 79628 0
Christopher James
Address 79628 0
PICU
Royal Children's Hospital
Flemington Road
Parkville
VIC 3052
Country 79628 0
Australia
Phone 79628 0
+61451955050
Fax 79628 0
Email 79628 0
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
169Study protocol    374142-(Uploaded-08-11-2018-11-45-42)-Study-related document.pdf



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.