None listed
Conditions
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, multicentre, randomised controlled trial aiming to evaluate whether in neonates, the use of TA in securing PIVC, compared to standard care, reduces catheter failure. The study will also assess complication rates, catheter dwell time, acceptability, cost-effectiveness and microbiological findings. A total of 204 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), and trial site. This trial will examine whether it is effect and safe, to use tissue adhesive to secure PIVC in neonates. Findings will inform the neonate's vascular access clinical practice.
Interventions
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
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.
Feasibility and effectiveness RCT:
The intervention will be administered by the assisting clinician (nurse or neonatologist) supporting the clinician performing the PIVC insertion.
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 place
Feasibility and effectiveness RCT: The intervention will be administered by the assisting clinician (nurse or neonatologist) supporting the clinician performing the PIVC insertion. 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. Educational Materials for Intervention Delivery To support the implementation of this intervention within neonatal clinical practice, we developed a 4-page educational resource for staff. This includes: (1) an overview of the study; (2) guidance on how the study is conducted within the neonatal unit; (3) a step-by-step instructional video demonstrating TA application on a neonatal mannequin, presented by a research nurse from the neonatal unit; (4) visual and narrative summary of the procedural steps for the intervention arm (TA group), extracted from the video; (5) instructions for daily PIVC site assessment and complication reporting; (6) PIVC removal procedures including skin care considerations and collection of biological samples for the site participating in biological sub study; and (7) follow-up procedures within 24 hours after catheter removal. This resource is designed to ensure procedural consistency and support staff confidence and safety during intervention delivery. The intervention training was introduced through a 15-minutes training session, which included a video demonstration of TA application with key tips, followed by a practical section's activities. During the practical component, clinicians practiced handling and applying TA on a mannequin and assessed appropriate volume and absorption during application.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to 4 Months
Healthy volunteers
No
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.
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
Outcome results
None listed