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Comparison of rates of extravasation injuries and phlebitis between fixed duration use of peripheral intravenous cannula and standard practice in newborns infants.

Comparison of rates of extravasation injuries and phlebitis between fixed duration use of peripheral intravenous cannula and standard practice in newborns infants.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000827538
Acronym
RESITE
Enrollment
113
Registered
2015-08-11
Start date
2015-08-04
Completion date
2017-07-16
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 (ne

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.

Sponsors

Dr Atul Malhotra
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
No minimum to 1 Months
Healthy volunteers
No

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.

Exclusion criteria

Babies who have concurrent use of intravenous access other than peripheral intravenous cannula

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 5, 2026