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

Introduction Peripheral intravenous catheters (PIVCs) are a vital part of care for hospitalized children. Despite commonality, up to 45% fail before treatment completion, with up to 20% of PIVCs resulting in an infusate‐associated injury, such as infiltration or extravasation. Biosensors developed to detect preclinical signs of intravenous catheter dysfunction have the potential to prevent significant injuries. Methods This multi‐site, type 1 hybrid effectiveness‐implementation randomized controlled trial will evaluate an IV biosensor for preventing infiltration/extravasation injuries in hospitalized neonates and infants. Participants up to 1 year of age who require a PIVC with continuous or moderate‐high risk infusates will be recruited from three Australian hospitals. Participants ( n = 532) will be randomized 1:1 to receive either standard observation plus IV biosensor or standard observation alone. The primary outcome is infiltration/extravasation injury occurrence, measured using the Cincinnati Children's Hospital Medical Centre Extravasation Harm Scale by the masked outcome assessment committee. Secondary outcomes include infiltration/extravasation severity, volume, treatment sequelae, quality of life, and cost‐effectiveness. The implementation context exploration will use mixed methods, including ecological momentary assessments and semi‐structured interviews, to evaluate barriers and facilitators for future implementation. Discussion The PATCH trial addresses a significant gap in evidence regarding the effectiveness and implementation of IV biosensor technology in preventing extravasation injuries in vulnerable infant and neonatal populations. The hybrid effectiveness‐implementation study will provide comprehensive data to inform both clinical practice and future implementation strategies.