Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000509662
Ethics application status
Approved
Date submitted
23/03/2023
Date registered
17/05/2023
Date last updated
28/04/2024
Date data sharing statement initially provided
17/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the effect of Topcial Glyceryl Trinitrate on radial artery diameter for catheterisation in newborns: a randomised controlled trial
Scientific title
Evaluation of Topical Glyceryl Trinitrate for radial arterial catheterisation in neonates: a randomised controlled trial
Secondary ID [1] 309273 0
Nil known
Universal Trial Number (UTN)
U1111-1290-1047
Trial acronym
TOP CAT trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
arterial cannulation 329464 0
critical care 329465 0
neonatal intensive care unit 329466 0
Condition category
Condition code
Emergency medicine 326400 326400 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Glyceryl trinitrate (GTN) 5mg (MinitranTM 5mg/24hour patch) will be applied for 30min, 45min or 60min. Neonates will be allocated to either the local GTN group or control group as described below. Glyceryl trinitrate is a registered medication on the Australian Therapeutic Goods Registry.
GTN GROUP: in this group, GTN patch 5mg will be applied to the neonate at the site of the radial arterial cannulation for 30 minutes (Group A, n = 15) or 45 minutes (Group B, n = 15) or 60min (Group C, n=15). Immediately after its application, the GTN patch will be covered with a CobanTM adhesive bandage to ensure blinding.

Per infant, only one arterial site will be studied to ensure the samples are independent.
Intervention code [1] 325731 0
Treatment: Other
Comparator / control treatment
Control group: In this group (Group D, n=15) a CobanTM adhesive bandage will be applied to the bare skin on the site of the radial artery with NO intervention to ensure blinding for 30min (n=5) or 45min (n=5) or 60min (n=5).
Per infant, only one arterial site will be studied to ensure the samples are independent.
Control group
Placebo

Outcomes
Primary outcome [1] 334252 0
The primary outcome will be assessed by an ultrasound of teh readial artery diameter. The change from baseline in the post intervention radial artery diameter will be calculated
Timepoint [1] 334252 0
Baseline, 30min or 45min or 60min post- commencement of intervention
Secondary outcome [1] 419974 0
Post-intervention cross-sectional radial arterial diameter in ipsilateral limb will be assessed by ultrasound of the radial artery.
Timepoint [1] 419974 0
30min or 45 min or 60min post-commencement of intervention
Secondary outcome [2] 419975 0
Post-intervention absolute and percentage change from baseline radial arterial diameter in ipsilateral limb will be assessed by ultrasound.
Timepoint [2] 419975 0
Baseline, 30min or 45min or 60min post commencement of intervention
Secondary outcome [3] 422084 0
Post-intervention absolute and percentage change from baseline radial arterial diameter in contralateral limb will be assessed by ultrasound..
Timepoint [3] 422084 0
Baseline, 30min or 45min or 60min post commencement of intervention
Secondary outcome [4] 422085 0
Will assess the side effects of topical GTN such as hypotension, methemoglobinemia and occurrence of a local reaction in the form of a skin rash under the patch using a study specific questionnaire.
Timepoint [4] 422085 0
Baseline, during intervention for a maximum period of 45min and immediate post intervention

Eligibility
Key inclusion criteria

1. Neonates >34 weeks of gestation admitted to Neonatal Intensive Care Unit (NICU) needing peripheral arterial line for sampling or invasive blood pressure monitoring.
2. Neonates >34 weeks of gestation admitted to NICU scheduled for elective surgery- general surgery needing peripheral arterial cannulation for hemodynamic monitoring or frequent blood sampling (Peri-operative).
Minimum age
34 Weeks
Maximum age
44 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Neonates with previous attempts at radial arterial cannulation, hematomas at cannulation site, abnormal Allen’s test, hypercoagulable state, coagulopathy, and peripheral vascular disease.
2. Neonates with unstable vital signs including hypotension, shock or significant arrythmias.
3. Neonates undergoing cardiac surgery
4. Neonates with increased intracranial pressure, intracranial haemorrhage, and recent use of Sildenafil.
5. Neonates with visible deformity in the radial artery area.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealment will be obtained using opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using a computer-generated sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We aim to recruit 60 patients (15 in each arm:1 Control and 3 GTN arms) over 12 months,
Justification of sample size is based on the desire to demonstrate that reasonable vasodilation with GTN patch application is achievable in our target study population. We will assume the measures of radial arterial diameter in study participants will have a mean of 0.76mm without treatment and a common within-group standard deviation of approximately 0.18 mm, as observed in a reference study of neonates aged 0-6 months . With a sample size of 15 for each group (1 control and 3 GTN-patch groups), the margin of error around the corresponding estimated population mean diameters is less than 1 mm, and an omnibus one-way ANOVA would have more than 80% power to conclude GTN patch application increases radial arterial diameter when the minimum treatment group mean differs from the control group by approximately 0.19 mm (alpha=0.05). Analyses based on change from baseline, which is our primary outcome, are expected to be more powerful than analyses that assess the cross-sectional diameters, and the detectable cross-sectional difference of 0.19 mm corresponds to an approximate 25% increase from estimated baseline values, which is of the order previously observed in children aged 0-2 years receiving subcutaneous injection of GTN , and substantially less than that observed after patch application in children aged 2-8 years (average 40% increase in radial arterial diameter after 30 minutes application and 70% increase after 1 hour). Furthermore, power will be increased by extending the assessment of GTN-induced vasodilation to an ANCOVA that reduces residual variation by adjusting for key demographic/clinical correlates of arterial diameter.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/05/2023
Actual
21/08/2023
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
60
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 313467 0
Hospital
Name [1] 313467 0
Perth Children's Hospital
Country [1] 313467 0
Australia
Primary sponsor type
Hospital
Name
Perth Children's Hospital(Child And Adolescent Health Service)
Address
15 Hospital Avenue, Nedlands 6009
Perth
Western Australia
Country
Australia
Secondary sponsor category [1] 315259 0
None
Name [1] 315259 0
Address [1] 315259 0
Country [1] 315259 0
Other collaborator category [1] 282592 0
University
Name [1] 282592 0
University of Western Australia
Address [1] 282592 0
35 Stirling Highway, Perth 6000
Western Australia
Country [1] 282592 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312663 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 312663 0
Ethics committee country [1] 312663 0
Australia
Date submitted for ethics approval [1] 312663 0
16/02/2023
Approval date [1] 312663 0
10/07/2023
Ethics approval number [1] 312663 0
RGS0000005763

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125474 0
Dr Deepika Wagh
Address 125474 0
Perth Children's Hospital (Child and Adolescent Health Service)
15 Hospital Avenue, Nedlands 6009
Perth
Western Australia
Country 125474 0
Australia
Phone 125474 0
+61 8 6456 5400
Fax 125474 0
Email 125474 0
[email protected]
Contact person for public queries
Name 125475 0
Deepika Wagh
Address 125475 0
Perth Children's Hospital (Child and Adolescent Health Service)
15 Hospital Avenue, Nedlands 6009
Perth
Western Australia
Country 125475 0
Australia
Phone 125475 0
+61 8 6456 5400
Fax 125475 0
Email 125475 0
[email protected]
Contact person for scientific queries
Name 125476 0
Deepika Wagh
Address 125476 0
Perth Children's Hospital (Child and Adolescent Health Service)
15 Hospital Avenue, Nedlands 6009
Perth
Western Australia
Country 125476 0
Australia
Phone 125476 0
+61 8 6456 5400
Fax 125476 0
Email 125476 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
Prerequisite for CAHS ethics approval - data sharing not permitted


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.