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.

中文翻译：

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I-KID 研究方案：临床使用的新型婴儿血液透析和超滤机的功效、结果和安全性评估：使用集群阶梯楔形设计的随机临床调查。

摘要 介绍：I-KID 研究旨在确定一种新型无 CE 标志婴儿血液透析机纽卡斯尔婴儿透析超滤系统 (NIDUS) 与英国目前可用的疗法相比的临床疗效、结果和安全性。NIDUS 专为 0.8 至 8 公斤小婴儿的肾脏替代治疗而设计。方法和分析：临床调查正在英国的六个中心进行。这是一项使用集群阶梯楔形设计的随机临床研究。该研究旨在招募 95 名需要在儿科重症监护病房接受肾脏替代治疗超过 20 个月的婴儿。