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Preventing InfusAte injuries throughout a Child's Hospitalization (PATCH): Study protocol for a type 1 hybrid

Amanda J Ullman1,2,3,4,5, Toni Day1,2,3, Rebecca Doyle1,2,3

  • 1The University of Queensland, Brisbane, Queensland, Australia.

Journal of Hospital Medicine
|December 10, 2025
PubMed

Insights

This study investigates an IV biosensor to prevent infiltration and extravasation injuries in hospitalized infants. The biosensor shows promise in reducing harm associated with peripheral intravenous catheters (PIVCs).

Area of Science:

  • Medical Devices
  • Pediatric Care
  • Clinical Trials

Background:

  • Peripheral intravenous catheters (PIVCs) are essential for hospitalized children, but up to 45% fail, and 20% cause injuries like infiltration or extravasation.
  • Biosensor technology offers a potential solution to detect early signs of catheter dysfunction and prevent associated injuries.

Purpose of the Study:

  • To evaluate the effectiveness and implementation of an IV biosensor in preventing infiltration/extravasation injuries in hospitalized neonates and infants.
  • To assess secondary outcomes including injury severity, treatment sequelae, quality of life, and cost-effectiveness.
  • To explore barriers and facilitators for future implementation of IV biosensor technology.

Main Methods:

  • A multi-site, type 1 hybrid effectiveness-implementation randomized controlled trial involving 532 neonates and infants up to 1 year of age.
  • Participants randomized 1:1 to standard observation plus IV biosensor or standard observation alone.
  • Primary outcome: infiltration/extravasation injury occurrence measured by the Extravasation Harm Scale; secondary outcomes assessed via mixed methods.

Main Results:

  • The study is designed to determine if IV biosensors reduce infiltration/extravasation injuries in infants.
  • Data on injury occurrence, severity, quality of life, and cost-effectiveness will be collected.
  • Implementation context will be explored through ecological momentary assessments and interviews.

Conclusions:

  • The PATCH trial addresses a critical evidence gap for IV biosensor technology in vulnerable infant populations.
  • This hybrid study will yield comprehensive data on effectiveness and implementation strategies.
  • Findings will inform clinical practice and guide future adoption of IV biosensors to prevent extravasation injuries.
Abstract

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