We are experiencing 4 week turn-around time in review of submissions and resubmissions. We recommend commencing this process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission. We currently do not have the capacity to expedite reviews.

Note also there are delays to review of updates. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620001335987
Ethics application status
Approved
Date submitted
7/11/2020
Date registered
11/12/2020
Date last updated
11/12/2020
Date data sharing statement initially provided
11/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the Pepi splint effectively secure an intravenous drip in hospitalised babies without causing skin injury?
Scientific title
Proof of concept project to determine if the Pepi Splint is effective and does not cause harm in 30 babies > 1000grams
Secondary ID [1] 302733 0
Nil known
Universal Trial Number (UTN)
U1111-1249-0775
Trial acronym
PEPI
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Iatrogenic skin injury in hospitalised babies 319562 0
Complications of the newborn 320015 0
Condition category
Condition code
Skin 317534 317534 0 0
Other skin conditions
Reproductive Health and Childbirth 317965 317965 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Pepi Splint will be applied and secure the PIVC on to the limb (either arm or leg) without the use of adhesive dressings. The splint will remain in place as long as the PIVC is required, which is commonly 12 to 72 hours. The duration of the study will be from the time that Pepi Splint is applied until removal. Therefore the duration of the study will vary for each participant.
The effectiveness of the Pepi Splint be measured using data routinely (hourly observations) collected by the bedside nurse, along with specific data collected about the duration and reasons for removal on a data collection record. Clinical photos will be taken and for later review by the Steering committee. In addition, the parents of babies who participate will be asked to complete a short (one page questionnaire) about what they like and dislike about Pepi Splint (see attached).
Intervention code [1] 318960 0
Prevention
Comparator / control treatment
No control group, proof of concept design
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325575 0
The proportion of babies where the Pepi Splint is determined by the bedside nurse to secure the peripheral intravenous cannula.
Timepoint [1] 325575 0
The duration that the peripheral intravenous cannula is required/lasts with the Pepi splint applied. This period is most commonly 12 - 72 hours
Primary outcome [2] 325945 0
The proportion of babies who experience and adverse event related to the Pepi splint. Adverse events include skin irritation or injury or pressure areas. As part of standard practice bedside neonatal nurses routinely assess and document hourly the skin and limbs of babies who require peripheral intravenous cannulas. So as, not to increase workloads, in an already busy environment, the Pepi Splint project will use these observations. If the bedside nurse determines that Pepi splint has caused harm, this will be discussed with the most senior clinician (likely to be a registrar or nurse practitioner) and a decision will be made and documented. The splint will be removed, and the necessary care will be given to the baby and family. Photos will be taken and an adverse event form will be sent to the Steering Committee within 24 hours of the event.
Timepoint [2] 325945 0
The duration of the peripheral intravenous cannula is required/lasts with the Pepi splint applied. This period is most commonly 12 - 72 hours.
Secondary outcome [1] 388426 0
The parents reported acceptability of the Pepi splint project as reported in the
questionnaire
Timepoint [1] 388426 0
Parents will be asked to complete a specifically designed questionnaire at the completion of the study.
Secondary outcome [2] 389629 0
The parents experience of participating in the Pepi Splint Project
Timepoint [2] 389629 0
Parents will be asked to complete a specifically designed questionnaire at the completion of the study.
Secondary outcome [3] 389724 0
The bedside nurses reported acceptability of the Pepi splint project as reported in the data collection sheet
Timepoint [3] 389724 0
Bedside nurses will complete a specifically designed data collection sheet at the completion of the study.

Eligibility
Key inclusion criteria
Medically fragile babies requiring a PIVC.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current weight < 1000g
Gestational age < 30 completed weeks gestation
Any skin conditions preventing the attachment of the Pepi splint
Major congenital abnormalities
Terminal conditions

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Statistical analysis will be performed with JMP v14 and R v 3.61.
Descriptive Analyses
Categorical data will be presented as number and percent and continuous data will be
presented as mean, standard deviation or median and inter-quartile range, as appropriate.
Count data will be presented as median and inter quartile range. Denominators will be given
for all outcomes
Primary Analyses
For the splint to be considered for use in clinical care we need to know if it will hold the
intravenous catheter in place and whether skin damage or irritation occurs.
Two exact 95% confidence intervals will be calculated, one for the proportion of babies in
which the Pepi Splint was judged by the clinical team to have supported the PIVC, and one
for the proportion of babies who experience an adverse event. Secondary outcomes will be
to determine the acceptability of the Pepi Splint to both parents and clinical staff.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 23083 0
New Zealand
State/province [1] 23083 0
Wellington

Funding & Sponsors
Funding source category [1] 306955 0
University
Name [1] 306955 0
Victoria University of Wellington
Address [1] 306955 0
PO Box 600
Wellington 6140
New Zealand
Country [1] 306955 0
New Zealand
Primary sponsor type
University
Name
Faculty of Health, Victoria University, Wellington
Address
PO Box 600
Wellington 6140
New Zealand
Country
New Zealand
Secondary sponsor category [1] 307513 0
None
Name [1] 307513 0
Not Applicable
Address [1] 307513 0
Not Applicable
Country [1] 307513 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307092 0
Central Health & Disability Ethics Committee (HDEC)
Ethics committee address [1] 307092 0
PO Box 5013
Wellington
6140
Ethics committee country [1] 307092 0
New Zealand
Date submitted for ethics approval [1] 307092 0
01/06/2020
Approval date [1] 307092 0
23/06/2020
Ethics approval number [1] 307092 0
20/CEN/47

Summary
Brief summary
Skin injury in hospitalised babies is common. Most babies who are admitted require a peripheral intravenous catheter (drip) for
medication and nutrition which are secured to the baby’s limb using a splint and adhesive dressings (elasoplast). Removing the adhesive elastoplast frequently tears the fragile skin, causing pain, increasing the risk of infection and possibly lasting skin damage.
The Pepi Splint is made from medical silicone and secures the drip to the baby without the need for elastoplast to be applied to the baby’s skin. We propose that the Pepi Splint will be effective at securing the drip and also acceptable to staff and parents.



Trial website
Not Applicable
Trial related presentations / publications
Not Applicable
Public notes

Contacts
Principal investigator
Name 106002 0
Dr Deborah Harris
Address 106002 0
School of Nursing, Midwifery and Health Practice
Victoria University of Wellington
PO Box 7625 Newtown, Wellington 6021
Country 106002 0
New Zealand
Phone 106002 0
+64 4 463 5180
Fax 106002 0
Email 106002 0
deborah.harris@vuw.ac.nz
Contact person for public queries
Name 106003 0
Dr Deborah Harris
Address 106003 0
School of Nursing, Midwifery and Health Practice
Victoria University of Wellington
PO Box 7625 Newtown, Wellington 6021
Country 106003 0
New Zealand
Phone 106003 0
+64 4 463 5180
Fax 106003 0
Email 106003 0
deborah.harris@vuw.ac.nz
Contact person for scientific queries
Name 106004 0
Dr Deborah Harris
Address 106004 0
School of Nursing, Midwifery and Health Practice
Victoria University of Wellington
PO Box 7625 Newtown, Wellington 6021
Country 106004 0
New Zealand
Phone 106004 0
+64 4 463 5180
Fax 106004 0
Email 106004 0
deborah.harris@vuw.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results will be available on request to the Principal Investigator.
When will data be available (start and end dates)?
These data will be available following publication and for the following 10 years.
Available to whom?
Researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of the Steering Committee.
Available for what types of analyses?
Data will be available for only to achieve the aims in the approved proposal.
How or where can data be obtained?
All requests should be addressed to the Principal Investigator
Deborah.Harris@vuw.ac.nz
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
Other
'Other' documents specified
Parent Questionnaire has been included for clarity. This document has been approved by the Central Ethics Committee
How or where can supporting documents be obtained?
Type [1] 9632 0
Study protocol
Citation [1] 9632 0
Link [1] 9632 0
Email [1] 9632 0
Other [1] 9632 0
Type [2] 9633 0
Ethical approval
Citation [2] 9633 0
Link [2] 9633 0
Email [2] 9633 0
Other [2] 9633 0
Type [3] 9997 0
Informed consent form
Citation [3] 9997 0
Link [3] 9997 0
Email [3] 9997 0
Other [3] 9997 0
Type [4] 9998 0
Other
Citation [4] 9998 0
Link [4] 9998 0
Email [4] 9998 0
Other [4] 9998 0
Summary results
No Results