ANZCTR - Registration

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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]

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

Phlebitis associated with peripheral intravenous cannula use in neonates

Condition category

Condition code

Public Health

Health service research

Inflammatory and Immune System

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]

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]

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]

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]

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]

Secondary outcome [2]

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]

Assessed at the end of study

Secondary outcome [3]

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]

Assessed at the end of study

Secondary outcome [4]

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]

Assessed at the end of study

Secondary outcome [5]

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]

Assessed at the end of study

Secondary outcome [6]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

28/07/2015

Actual

4/08/2015

Date of last participant enrolment

Anticipated

Actual

16/07/2017

Date of last data collection

Anticipated

Actual

20/07/2017

Sample size

Target

104

Accrual to date

Final

113

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Monash Medical Centre - Clayton campus - Clayton

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Unfunded

Address [1]

Unfunded

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee, Monash Health

Ethics committee address [1]

Research Support Services, Monash Medical Centre, 246 Clayton Road, Clayton VIC 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/04/2015

Approval date [1]

19/05/2015

Ethics approval number [1]

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

Dr Atul Malhotra

Address

Monash Newborn, Monash Medical Centre,
246 Clayton Road,
Clayton VIC 3168

Country

Australia

Phone

+61 3 95945191

Fax

[email protected]

Contact person for public queries

Name

Atul Malhotra

Address

Monash Newborn, Monash Medical Centre,
246 Clayton Road,
Clayton VIC 3168

Country

Australia

Phone

+61 3 95945191

Fax

[email protected]

Contact person for scientific queries

Name

Atul Malhotra

Address

Monash Newborn, Monash Medical Centre,
246 Clayton Road,
Clayton VIC 3168

Country

Australia

Phone

+61 3 95945191

Fax

[email protected]

No information has been provided regarding IPD availability

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

Source	Title	Year of Publication	DOI
Embase	Elective replacement of intravenous cannula in neonates-a randomised trial.	2018	https://dx.doi.org/10.1007/s00431-018-3234-7

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically