The 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.
Keyword(s):
The Uk
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Abstract 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 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 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.
2016 ◽
Vol 375
(2)
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pp. 122-133
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