I-KID study protocol: evaluation of efficacy, outcomes and safety of a new infant haemodialysis and ultrafiltration machine in clinical use: a randomised clinical investigation using a cluster stepped-wedge design.

Autor:	Lambert HJ; Paediatric Nephrology, Great North Children's Hospital, Newcastle Upon Tyne, UK.; Department of Child Health, Newcastle University, Newcastle upon Tyne, UK., Sharma S; Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK., Matthews JNS; Department of Mathematics, Statistics & Physics and Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.
Jazyk:	angličtina
Zdroj:	BMJ paediatrics open [BMJ Paediatr Open] 2021 Oct 18; Vol. 5 (1), pp. e001224. Date of Electronic Publication: 2021 Oct 18 (Print Publication: 2021).
DOI:	10.1136/bmjpo-2021-001224
Abstrakt:	Introduction: The 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 with currently available therapy in the UK. NIDUS is specifically designed for renal replacement therapy in small babies between 0.8 and 8 kg. Methods and Analysis: The 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. Ethics and Dissemination: The study has high parent and public involvement at all stages in its design and parents will be involved in dissemination of results to parents and professionals via publications, conference proceedings and newsletters. The study has has ethics permissions from Tyne and Wear South Research Ethics Committee. Trial Registration Numbers: IRAS ID number: 170 481MHRA Reference: CI/2017/0066ISRCT Number: 13 787 486CPMS ID number: 36 558NHS REC reference: 16/NE/0008Eudamed number: CIV-GB-18-02-023105Link to full protocol v6.0: https://fundingawards.nihr.ac.uk/award/14/23/26. Competing Interests: Competing interests: Dr Malcolm Coulthard is named on the patent and will receive some royalties if the NIDUS device goes into commercial production. The Newcastle upon Tyne NHS Foundation Trust will receive some royalties if the NIDUS device goes into commercial production.Allmed, the device manufacturers, are providing 17 NIDUS devices for loan to sites for the I-KID study and for potential compassionate use in the post-study period. NIDUS consumables are purchased as per normal clinical care. The rest of the authors have completed the COI form and have no competing interests to declare. (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)
Databáze:	MEDLINE
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