Abstract
AbstractIntroductionThe I-KID study aims to determine the clinical efficacy, outcomes and safety of a novel non-CE-marked infant haemodialysis machine, the Newcastle Infant Dialysis Ultrafiltration System (NIDUS), compared to currently available therapy in the UK. NIDUS is specifically designed for renal replacement therapy in small babies between 0.8 and 8 kilograms.Methods and analysisThe clinical investigation is taking place in six UK centres. This is a randomised clinical investigation using a cluster stepped-wedge design. The study aims to recruit 95 babies requiring renal replacement therapy in paediatric intensive care units over 20 months.RegistrationIRAS ID number: 170481MHRA Reference: CI/2017/0066ISRCT Number: 13787486CPMS ID number: 36558NHS REC reference: 16/NE/0008Eudamed number: CIV-GB-18-02-023105Link to full protocol v6.0: https://fundingawards.nihr.ac.uk/award/14/23/26What is known about this subjectBabies in paediatric intensive care unit (PICU) may develop acute renal failure and require therapeutic support.Renal replacement options for babies are limited because of their small size and limitations of technology.Current haemodialysis and filtration systems in use in UK are not recommended or licensed for children under 8kg.What this study hopes to addRenal replacement methods for infants under 8kg in PICU will be compared.The efficacy, outcomes and safety of a new infant haemodialysis device will be assessed.Usability of the new device in normal clinical settings outside of the development centre will be examined.
Publisher
Cold Spring Harbor Laboratory