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Trial registered on ANZCTR
Registration number
ACTRN12625000434493
Ethics application status
Approved
Date submitted
24/04/2025
Date registered
9/05/2025
Date last updated
9/05/2025
Date data sharing statement initially provided
9/05/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
PENGUIN Trial: Testing if Glue Can Safely Secure Intravenous (IV) Lines in Newborns
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Scientific title
PENGUIN trial: PEripheral INtravenous Catheter Glue In Newborns: A feasibility trial comparing tissue adhesive and standard care dressing
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Secondary ID [1]
314281
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None
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Universal Trial Number (UTN)
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Trial acronym
PENGUIN
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Peripheral intravenous catheter complications in neonates
337222
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Peripheral intravenous catheter failures in neonates
337221
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Condition category
Condition code
Skin
333629
333629
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0
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Other skin conditions
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Reproductive Health and Childbirth
333703
333703
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0
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Complications of newborn
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Injuries and Accidents
333630
333630
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention will be administered by the assisting clinician (nurse or neonatologist) supporting the clinician performing the PIVC insertion.
The intervention training was introduced through a two-hour training session, which included a video demonstration of TA application with key tips, followed by two practical sections activities. During the practical component, clinicians practiced handling and applying TA on a mannequin and assessed appropriate volume and absorption during application.
After successful insertion, 1–2 drops of tissue adhesive (SecurePortIV® – Adhezion Biomedical) will be applied at the insertion site, followed by the standard PIVC securement:
3M™ Tegaderm™ I.V. Transparent Film Dressing (1610, Paediatric Peripheral, 5 cm x 5.7 cm) and two sterile fabric adhesive chevrons, one placed around the hub and the other over the hub.
All clinicians involved in applying the tissue adhesive will receive targeted training to ensure protocol adherence.
Participants will only be enrolled if the PIVC is expected to remain in place for more than 24 hours, as devices expected to be removed within 24 hours are excluded.
If a replacement PIVC is required, no additional tissue adhesive will be applied; subsequent insertions will receive standard care dressing only.
Adherence to the intervention will be monitored through daily review of PIVC site forms and medical records, including documentation of tissue adhesive use, dressing integrity, and device removal. Research Nurses will follow participants daily until PIVC removal and again within 24 hours post-removal.
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Intervention code [1]
330893
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Treatment: Devices
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Comparator / control treatment
The comparator treatment will follow usual institutional practice. PIVC insertion will be performed by a neonatologist or consultant, with assistance from a nurse or medical who will apply the standard PIVC securement:
3M™ Tegaderm™ I.V. Transparent Film Dressing (1610, Paediatric Peripheral, 5 cm x 5.7 cm) and two sterile fabric adhesive chevrons, one placed around the hub and the other over the hub.
Participants will only be enrolled if the PIVC is expected to remain in place for more than 24 hours.
Adherence to the comparator will be monitored via daily review of PIVC site forms and medical records, including confirmation that no tissue adhesive was used, dressing integrity, and time/reason for removal. Research Nurses will follow participants daily until PIVC removal and once more within 24 hours post-removal.
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Control group
Active
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Outcomes
Primary outcome [1]
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Feasibility (composite primary outcome including: eligibility rate, recruitment rate, protocol adherence, retention, missing data rate, and acceptability)
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Assessment method [1]
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Eligibility: assessed via audit of screening logs (percentage of screened patients meeting all inclusion and no exclusion criteria, with more than seventy-five percent considered acceptable) Recruitment: assessed via enrolment logs (percentage of eligible patients providing informed consent, with more than ninety percent considered acceptable) Protocol adherence: assessed through daily review of medical records and PIVC site forms (more than ninety percent of participants receiving the allocated intervention as planned) Retention: monitored via follow-up logs (attrition of less than five percent of participants will be considered acceptable) Data completeness: assessed through study forms and databases (less than five percent of total outcome data missing will be considered acceptable) Acceptability: - Neonatal: assessed by Premature Infant Pain Profile-Revised (PIPP-R) at PIVC removal; pain scores less than twelve will be considered acceptable - Parent and clinician: assessed via 11-point numeric rating scale at two time points (application of glue and PIVC removal); scores of seven or higher will be considered acceptable
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Timepoint [1]
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Eligibility and recruitment: during screening and enrolment Protocol adherence, retention and data completeness: from PIVC insertion until removal and 24-hour follow-up Neonatal pain: at time of PIVC removal Parent and clinician feedback: at glue application and at PIVC removal
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Secondary outcome [1]
446778
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PIVC failure
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Assessment method [1]
446778
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Defined as premature cessation of the PIVC function for any reason prior to completion of planned treatment. The failure data will be collected by the research nurse and entered directly into a purpose-built case report form (CRF) in REDCap® (Research Electronic Data Capture), hosted by the University of Queensland on password-protected devices. Research nurses will follow participants daily until PIVC removal and again within 24 hours post-removal to assess for catheter function and complications.
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Timepoint [1]
446778
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Time of unplanned removal
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Secondary outcome [2]
446779
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PIVC complications (Laboratory confirmed bloodstream infection (positive blood culture), Exit site infection, Skin injury, Phlebitis, Dislodgment, Occlusion, Infiltration/extravasation, Leakage)
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Assessment method [2]
446779
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Laboratory confirmed bloodstream infection (positive blood culture), as defined in CDC criteria. Exit site infection: defined as the presence of redness, hardness, and/or tenderness within 2 cm of catheter exit site; possible with other signs and symptoms of infection, such as fever or purulent drainage at exit site. Any skin injury type and/or classification at PIVC site: defined as the presence of damage to skin or underlying tissue resulting a combination of etiologies (e.g, mechanical forces, moisture), burn or other reaction acquired in relation to or because of hospital care. Also including catheter-associated skin injury (CASI) and including any subcategories, such as allergic dermatitis: skin stripping (removal of 1 or more layers of the skin occurring following traumatic removal of adhesive tape or dressing); skin tear (wound caused by shear, friction, and/or blunt force resulting in separation of skin layers with partial or full thickness; tension blister (wound caused by shear force as a result of distension of skin under an unyielding adhesive tape or dressing). Skin integrity assessment will be confirmed by a blind expert's review while PIVC is on site and within 72 hours of removal. Phlebitis: defined as the presence of one or more of the following symptoms: pain or tenderness, redness, swelling, purulence and/or a palpable cord. Dislodgement: Defined as unintentional complete or partial dislodgement of the catheter. Occlusion, whether partial or total, including instances where the PIVC encounters resistance during infusion or cannot be used for infusion. Infiltration or extravasation: defined as the movement of fluids into the surrounding tissues. Leakage, defined as the fluid escaping around catheter site.
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Timepoint [2]
446779
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Daily during the study period and PIVC use, with a follow-up within 24 hours post-removal
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Secondary outcome [3]
446780
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Catheter dwell time
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Assessment method [3]
446780
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Time in hours from insertion to removal due the treatment completion or complication. Time in hours from PIVC insertion to removal (whether due to treatment completion or complication) will be calculated based on the insertion and removal times documented directly in the REDCap® case report form (CRF) by the research nurse. These timestamps will be recorded in real time during the procedure and daily follow-up assessments.
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Timepoint [3]
446780
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From PIVC insertion untill removal
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Eligibility
Key inclusion criteria
Neonates with a corrected gestational age of 32 weeks or greater, until discharge from the reference unit requiring a PIVC insertion.
Inclusivity will be prioritised for all families, when screening and recruiting by utilising services, such as Indigenous Liaison Officers and Translation Services.
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Minimum age
0
Hours
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Maximum age
4
Months
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Neonates with known/inherited skin conditions will be excluded (e.g. scalded skin syndrome).
Long peripheral IVs
Peripheral IV anticipated to be removed in 24 hours or less
Neonates previously enrolled in the study or another study with similar or concurrent outcome
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed randomisation will be performed using RedCap by research nurses. Randomisation allocation will only be revealed after participant enrolment to ensure allocation concealment.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated with interactive web-based randomisation (UQ REDCap), with 1:1 group allocation and stratification for days after birth (<15 or 15 days or greater) using block sizes of 4 and 6 (block sizes randomly selected in 1:1 ratio).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
2/06/2025
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Actual
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Date of last participant enrolment
Anticipated
2/06/2026
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Actual
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Date of last data collection
Anticipated
2/06/2027
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
318798
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Charities/Societies/Foundations
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Name [1]
318798
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The Australian and New Zealand Intensive Care Foundation
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Address [1]
318798
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Country [1]
318798
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Australia
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Primary sponsor type
University
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Name
The University of Queensland
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
321241
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Address [1]
321241
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Country [1]
321241
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317406
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Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
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Ethics committee address [1]
317406
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http://www.childrens.health.qld.gov.au/research/human-research-ethics-committee
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Ethics committee country [1]
317406
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Australia
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Date submitted for ethics approval [1]
317406
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14/02/2025
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Approval date [1]
317406
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16/04/2025
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Ethics approval number [1]
317406
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HREC/25/QCHQ/115570
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Summary
Brief summary
Peripheral intravenous catheters (PIVCs) are commonly used in neonatal care to deliver fluids and medications. However, due to the fragility of neonatal skin and veins, PIVCs are prone to failure, which may lead to treatment interruptions and additional procedures. Tissue adhesive is a medical-grade glue that has shown promise in improving PIVC securement in adult and paediatric populations, but there is limited high-quality evidence regarding its use in neonates. The PENGUIN trial is a two-arm pilot randomised controlled trial aiming to evaluate the feasibility of a larger effectiveness study on the use of tissue adhesive in neonatal PIVC securement. A total of 100 neonates requiring PIVC insertion will be enrolled and randomised to receive either: (i) standard care with a bordered polyurethane dressing, or (ii) standard care plus tissue adhesive applied at the insertion site. Randomisation will be stratified by age at enrolment (less than 15 days or equal and greater than 15 days of life). This trial will examine whether it is feasible, including the safety, to use tissue adhesive to secure PIVC in neonates. Findings will inform the design and safety of a larger future trial.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Sabrina de Souza
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Address
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Centre for Children's Health Research. 62 Graham St, South Brisbane QLD 4101
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Country
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Australia
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Phone
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+61730697626
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Sabrina de Souza
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Address
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Centre for Children’s Health Research. 62 Graham St, South Brisbane QLD 4101
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Country
140963
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Australia
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Phone
140963
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+61730697626
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Fax
140963
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Email
140963
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[email protected]
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Contact person for scientific queries
Name
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Sabrina de Souza
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Address
140964
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Centre for Children’s Health Research. 62 Graham St, South Brisbane QLD 4101
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Country
140964
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Australia
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Phone
140964
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+61730697626
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Fax
140964
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Email
140964
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
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.
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