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Trial registered on ANZCTR


Registration number
ACTRN12619000798167
Ethics application status
Approved
Date submitted
22/05/2019
Date registered
30/05/2019
Date last updated
30/05/2019
Date data sharing statement initially provided
30/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Reducing peripheral intravenous cannula failure in neonates
Scientific title
Effect of a splint and intravenous protection device on peripheral intravenous cannula failure in neonates.
Secondary ID [1] 298307 0
Nil
Universal Trial Number (UTN)
Trial acronym
IV-Protect
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
IV cannula failure
312936 0
IV extravasation 312937 0
Condition category
Condition code
Reproductive Health and Childbirth 311429 311429 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised controlled trial to assess whether using a specifically designed splint and protection device may be useful to prevent (peripheral intravenous cannula) PIVC failure as compared to standard splinting and securement in the neonatal population. Specific splint and IV protective product (I.V. house, Inc, MO, USA) – 939S-Ultra TLC Foam Padded Wrist Splint with Two Straps and Velcro Closure, or 949XS TLC Foam Padded Foot Splint with Two Straps and Velcro Closure; in conjunction with the I.V. House 330 Series I.V. House UltraDressing IV site protector.
Intervention will be administered by any health professional inserting and/or securing the PIVC. The intervention will continue for the life of that PIVC which may be minutes, hours or days till the PIVC is removed. This is a likely to be less than 7 days in most cases.
Adherence to intervention will be ensured by observation and cannula log maintained by bedside nurses.
Intervention code [1] 314538 0
Treatment: Devices
Comparator / control treatment
Splinting and dressing as per current standard care at Monash Newborn. This includes splinting with a Parker Healthcare (Mitcham, VIC, Australia) APM602 disposable IV arm board with flex insert, secured with Leukoplast (BSN medical GmbH, Hamburg, Germany) tape
Control group
Active

Outcomes
Primary outcome [1] 320150 0
Rates of PIVC failure due to any cause (as observed clinically and recorded on cannula log)
Timepoint [1] 320150 0
At end of need for PIVC for that episode (only one PIVC insertion per patient will be randomised). A non-failed PIVC will indicate a PIVC which is electively removed, when it is no longer required.
Secondary outcome [1] 370714 0
Rates of extravasation (Clinical observation)
Timepoint [1] 370714 0
At PIVC removal or end of PIVC use
Secondary outcome [2] 370767 0
Rates of phlebitis (Clinical observation)
Timepoint [2] 370767 0
At PIVC removal or end of PIVC use
Secondary outcome [3] 370768 0
Rates of dislodgement (Clinical observation)
Timepoint [3] 370768 0
At PIVC removal or end of PIVC use
Secondary outcome [4] 370769 0
Rates of any other event related to PIVC (Clinical observation)
Timepoint [4] 370769 0
At PIVC removal or end of PIVC use

Eligibility
Key inclusion criteria
All neonates admitted to the neonatal unit at Monash Children's Hospital, Clayton with a gestation at birth of more than 35 weeks and birth weight of more than 2500g who require a peripheral intravenous cannula.
Only one cannulation per neonate will be included in the study, and this will preferably be the first cannulation.
Minimum age
0 Hours
Maximum age
28 Days
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neonates who are expected to require the PIVC for a period of less than 24 hours will be excluded from the study

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

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 in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13809 0
Monash Children’s Hospital - Clayton
Recruitment postcode(s) [1] 26562 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 302847 0
Hospital
Name [1] 302847 0
Monash Health
Address [1] 302847 0
246 Clayton Rd
Clayton Vic 3168
Country [1] 302847 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Road
Clayton Vic 3168
Country
Australia
Secondary sponsor category [1] 302815 0
None
Name [1] 302815 0
None
Address [1] 302815 0
None
Country [1] 302815 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303424 0
Monash HREC
Ethics committee address [1] 303424 0
246 Clayton Road
Clayton VIC 3168
Ethics committee country [1] 303424 0
Australia
Date submitted for ethics approval [1] 303424 0
Approval date [1] 303424 0
20/05/2019
Ethics approval number [1] 303424 0

Summary
Brief summary
Peripheral IV cannulation is one of the most frequently performed invasive procedures in the hospital setting, and an essential means of providing hydration, nutrition and medication to admitted patients, including neonates . The insertion, monitoring and maintenance of these devices, to prevent complications, are an important component of neonatal nursing care. The most common complications of PIVC use include extravasation, infiltration, occlusion, infection, and phlebitis - accounting for the failure and removal of 95% of PIVCs. Although these complications are usually minor, some neonates may experience serious, or even life-threatening sequelae, with the potential for long-term functional difficulties, significant scarring, and psychological effects.
The current failure rate of PIVC in the neonatal population is estimated at around 60%, however the optimal securement method of a PIVC has not been well established. We have designed a randomised controlled trial to assess whether using a specifically designed splint and protection device may be useful to prevent PIVC failure as compared to standard splinting and securement in the neonatal population.
Our hypothesis is that the specifically designed splint and protection device will significantly decrease PIVC failure as compared to standard splinting and securement in the neonatal population.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93630 0
Dr Atul Malhotra
Address 93630 0
Monash Health
246 Clayton Rd
Clayton VIC 3168
Country 93630 0
Australia
Phone 93630 0
+61 3 85723650
Fax 93630 0
Email 93630 0
atul_m75@hotmail.com
Contact person for public queries
Name 93631 0
Dr Atul Malhotra
Address 93631 0
Monash Health
246 Clayton Rd
Clayton VIC 3168
Country 93631 0
Australia
Phone 93631 0
+61 3 85723650
Fax 93631 0
Email 93631 0
atul_m75@hotmail.com
Contact person for scientific queries
Name 93632 0
Dr Atul Malhotra
Address 93632 0
Monash Health
246 Clayton Rd
Clayton VIC 3168
Country 93632 0
Australia
Phone 93632 0
+61 3 85723650
Fax 93632 0
Email 93632 0
atul_m75@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results