Trial Review

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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
Scientific title
PENGUIN trial: PEripheral INtravenous Catheter Glue In Newborns: A feasibility trial comparing tissue adhesive and standard care dressing
Secondary ID [1] 314281 0
None
Universal Trial Number (UTN)
Trial acronym
PENGUIN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral intravenous catheter failures in neonates 337221 0
Peripheral intravenous catheter complications in neonates 337222 0
Condition category
Condition code
Skin 333629 333629 0 0
Other skin conditions
Injuries and Accidents 333630 333630 0 0
Other injuries and accidents
Reproductive Health and Childbirth 333703 333703 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 330893 0
Treatment: Devices
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.
Control group
Active

Outcomes
Primary outcome [1] 341207 0
Feasibility (composite primary outcome including: eligibility rate, recruitment rate, protocol adherence, retention, missing data rate, and acceptability)
Timepoint [1] 341207 0
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
Secondary outcome [1] 446778 0
PIVC failure
Timepoint [1] 446778 0
Time of unplanned removal
Secondary outcome [2] 446779 0
PIVC complications (Laboratory confirmed bloodstream infection (positive blood culture), Exit site infection, Skin injury, Phlebitis, Dislodgment, Occlusion, Infiltration/extravasation, Leakage)
Timepoint [2] 446779 0
Daily during the study period and PIVC use, with a follow-up within 24 hours post-removal
Secondary outcome [3] 446780 0
Catheter dwell time
Timepoint [3] 446780 0
From PIVC insertion untill removal

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.
Minimum age
0 Hours
Maximum age
4 Months
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
Concealed randomisation will be performed using RedCap by research nurses. Randomisation allocation will only be revealed after participant enrolment to ensure allocation concealment.
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).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
2/06/2026
Actual
Date of last data collection
Anticipated
2/06/2027
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 318798 0
Charities/Societies/Foundations
Name [1] 318798 0
The Australian and New Zealand Intensive Care Foundation
Country [1] 318798 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 321241 0
None
Name [1] 321241 0
Address [1] 321241 0
Country [1] 321241 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317406 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 317406 0
Ethics committee country [1] 317406 0
Australia
Date submitted for ethics approval [1] 317406 0
14/02/2025
Approval date [1] 317406 0
16/04/2025
Ethics approval number [1] 317406 0
HREC/25/QCHQ/115570

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

Contacts
Principal investigator
Name 140962 0
Dr Sabrina de Souza
Address 140962 0
Centre for Children's Health Research. 62 Graham St, South Brisbane QLD 4101
Country 140962 0
Australia
Phone 140962 0
+61730697626
Fax 140962 0
Email 140962 0
[email protected]
Contact person for public queries
Name 140963 0
Sabrina de Souza
Address 140963 0
Centre for Children’s Health Research. 62 Graham St, South Brisbane QLD 4101
Country 140963 0
Australia
Phone 140963 0
+61730697626
Fax 140963 0
Email 140963 0
[email protected]
Contact person for scientific queries
Name 140964 0
Sabrina de Souza
Address 140964 0
Centre for Children’s Health Research. 62 Graham St, South Brisbane QLD 4101
Country 140964 0
Australia
Phone 140964 0
+61730697626
Fax 140964 0
Email 140964 0
[email protected]

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.