RecruitingACTRN12619000798167

Reducing peripheral intravenous cannula failure in neonates

Effect of a splint and intravenous protection device on peripheral intravenous cannula failure in neonates.


Sponsor

Monash Health

Enrollment

100 participants

Start Date

Jul 31, 2019

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 0 HourssMax Age: 28 Dayss

Plain Language Summary

Simplified for easier understanding

A peripheral intravenous cannula (PIVC) — the small plastic tube inserted into a vein to deliver fluids or medications — is one of the most common medical devices used in hospitals. In newborns, these are especially tricky because babies' veins are tiny and fragile. Currently, around 60% of PIVCs in newborns fail before they are no longer needed, requiring a new needle insertion — which is painful and distressing for both baby and family. This study is testing whether a specially designed splint and protection device can reduce PIVC failure rates in newborns compared to the standard method of securing the cannula. Babies at Monash Children's Hospital who need a PIVC and were born after 35 weeks gestation with a birth weight over 2500 grams will be randomly assigned to one of the two securement methods. The study covers only one cannula per baby (ideally the first one). Babies who are only expected to need the PIVC for less than 24 hours are not included. Reducing PIVC failure could spare babies from repeated painful procedures and make it easier for nurses and doctors to deliver essential treatments to this vulnerable group.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 standar

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.


Locations(1)

Monash Children’s Hospital - Clayton

VIC, Australia

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ACTRN12619000798167


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