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Trial registered on ANZCTR


Registration number
ACTRN12615000827538
Ethics application status
Approved
Date submitted
9/06/2015
Date registered
11/08/2015
Date last updated
28/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of rates of extravasation injuries and phlebitis between fixed duration use of peripheral intravenous cannula and standard practice in newborns infants.
Scientific title
Comparison of rates of extravasation injuries and phlebitis between fixed duration use of peripheral intravenous cannula and standard practice in newborns infants.
Secondary ID [1] 286862 0
NIL
Universal Trial Number (UTN)
U1111-1171-0011
Trial acronym
RESITE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extravasation injuries associated with peripheral intravenous cannula use in neonates 295258 0
Phlebitis associated with peripheral intravenous cannula use in neonates 295411 0
Condition category
Condition code
Public Health 295504 295504 0 0
Health service research
Inflammatory and Immune System 295918 295918 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This research aims to study the rates of infiltration/extravasation injuries and phlebitis between infants who have an elective removal and re-site of their PIVC at 72 hours compared to those in whom the PIVC is changed due to clinical concerns only. The study follows one episode of PIVC use per baby enrolled into the study. For babies randomised to the elective resite group, the babies will have his/her PIVC electively re-sited every 72 hours. The re-site will be performed by medical staff (neonatal registrar, fellow or consultant).
All participants' PIVC site will be monitored by nursing staff for signs of infiltration and phlebitis injuries. The nursing staff are required to document presence or absence of these signs every shift (morning, afternoon or night).
If the PIVC sites show clinical indication for replacement prior to 72 hours it will be re-sited.
Intervention code [1] 292036 0
Prevention
Comparator / control treatment
The comparator, which is the standard practice group in this project, is the group of babies whose peripheral intravenous cannulas will be monitored and re-sited if there were signs of complications.
Control group
Active

Outcomes
Primary outcome [1] 295242 0
Rates of extravasation injury. This will be assessed by the presence of signs of extravasation injury identified by nursing and medical staff. These signs include: distress with flushing, swelling at site, skin blanching, delayed capillary refill time, blistering of skin, absent peripheral pulse. Nursing staff will be required to fill out an observation log to indicate if these signs occur during their shift. If signs occur, this will prompt the need for medical review to assess for need of PIVC re-site.
Timepoint [1] 295242 0
Participants will be monitored until the peripheral intravenous cannula is no longer required for that episode of intravenous therapy use. Duration of monitoring therefore depends on individual participant's situation. Rate of infiltration injury will be assessed at the end of study
Secondary outcome [1] 315169 0
Rates of phlebitis. This will be assessed by the presence of signs of phlebitis injury identified by nursing and medical staff. These signs include: distress with flushing, erythema, induration, palpable venous cord, and pyrexia. Nursing staff will be required to fill out an observation log to indicate if these signs occur during their shift. If signs occur, this will prompt the need for medical review to assess for need of PIVC re-site.
Timepoint [1] 315169 0
Participants will be monitored until the peripheral intravenous cannula is no longer required for that episode of intravenous therapy use. Duration of monitoring therefore depends on individual participant's situation. Rate of phlebitis will be assessed at the end of study
Secondary outcome [2] 315170 0
To investigate if gestational age of participant is associated with development of extravasation injury and phlebitis. The information on gestational age of the participant at birth will be collected at enrolment on our registration pro forma. The information will be used to see if there is link between gestational age and complication rates of peripheral IV cannula use.
Timepoint [2] 315170 0
Assessed at the end of study
Secondary outcome [3] 315445 0
To investigate if birthweight of participant is associated with development of extravasation injury and phlebitis. The information on participant's birthweight will be collected at enrolment on our registration pro forma. The information will be used to see if there is link between gestational age and complication rates of peripheral IV cannula use.
Timepoint [3] 315445 0
Assessed at the end of study
Secondary outcome [4] 315446 0
To investigate if the site of PIVC placement is associated with risk of developing extravasation injury and phlebitis. The information on where the site of PIVC insertion is will be collected on our participant registration pro forma. The information will be used to see if there is link between site of PIVC insertion and complication rates of peripheral IV cannula use.
Timepoint [4] 315446 0
Assessed at the end of study
Secondary outcome [5] 315447 0
To investigate if the admission diagnosis of participant is associated with risk of developing extravasation injury and phlebitis. The information on participant's admission diagnosis will be collected at enrolment. The information will be collected on our participant registration pro forma. The information will be used to see if there is link between participants' medical condition(s) and complication rates of peripheral IV cannula use.
Timepoint [5] 315447 0
Assessed at the end of study
Secondary outcome [6] 315701 0
To investigate if the type of infusate given is associated with risk of developing extravasation injury and phlebitis. The information on the type of infusate given will be collected at enrolment and also during use of PIVC through our participant registration pro forma and also our nursing observation log. The information will be used to see if there is link between use of different infusates and complication rates of peripheral IV cannula use.
Timepoint [6] 315701 0
Assessed at the end of study

Eligibility
Key inclusion criteria
Newborns who are born at least 32 weeks of gestation admitted into Neonatal Intensive Care Unit and Special Care Nursery who requires a peripheral intravenous cannula for treatment and management.
Minimum age
No limit
Maximum age
1 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Babies who have concurrent use of intravenous access other than peripheral intravenous cannula

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)
Allocation is concealed via use of sealed opaque envelope for randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Assuming that the current rate of infiltration/extravasation injury is approximately 50%, we expect a 50% reduction with the intervention (i.e. a reduction to 25% incidence). We will need a sample size of 52 infants in each group to give the study a power of 80% and an alpha error of 0.05.

Recruitment
Recruitment status
Completed
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] 3888 0
Monash Medical Centre - Clayton campus - Clayton

Funding & Sponsors
Funding source category [1] 291421 0
Self funded/Unfunded
Name [1] 291421 0
Unfunded
Address [1] 291421 0
Unfunded
Country [1] 291421 0
Primary sponsor type
Individual
Name
Dr Atul Malhotra
Address
Monash Newborn, Southern Health, 246 Clayton Road, Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 290097 0
None
Name [1] 290097 0
Address [1] 290097 0
Country [1] 290097 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292973 0
Human Research Ethics Committee, Monash Health
Ethics committee address [1] 292973 0
Research Support Services, Monash Medical Centre, 246 Clayton Road, Clayton VIC 3168
Ethics committee country [1] 292973 0
Australia
Date submitted for ethics approval [1] 292973 0
29/04/2015
Approval date [1] 292973 0
19/05/2015
Ethics approval number [1] 292973 0
15200A

Summary
Brief summary
This study is to compare the rates of extravasation injury and phlebitis between newborn infants who have an elective re-site of their peripheral intravenous cannula (PIVC) at 72 hours compared to those in whom the PIVC is changed due to clinical concerns only. We hypothesise that the incidence rates of extravasation injury and phlebitis will reduce by half in our study group with the intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57838 0
Dr Atul Malhotra
Address 57838 0
Monash Newborn, Monash Medical Centre,
246 Clayton Road,
Clayton VIC 3168
Country 57838 0
Australia
Phone 57838 0
+61 3 95945191
Fax 57838 0
Email 57838 0
atul.malhotra@monash.edu
Contact person for public queries
Name 57839 0
Dr Atul Malhotra
Address 57839 0
Monash Newborn, Monash Medical Centre,
246 Clayton Road,
Clayton VIC 3168
Country 57839 0
Australia
Phone 57839 0
+61 3 95945191
Fax 57839 0
Email 57839 0
atul.malhotra@monash.edu
Contact person for scientific queries
Name 57840 0
Dr Atul Malhotra
Address 57840 0
Monash Newborn, Monash Medical Centre,
246 Clayton Road,
Clayton VIC 3168
Country 57840 0
Australia
Phone 57840 0
+61 3 95945191
Fax 57840 0
Email 57840 0
atul.malhotra@monash.edu

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary