I-KID 研究方案：评估新型婴儿血液透析和超滤机在临床应用中的疗效、结局和安全性：采用群组级联 stepped-wedge 设计的随机临床研究。
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.
机构信息
Paediatric Nephrology, Great North Children's Hospital, Newcastle Upon Tyne, UK.
Department of Child Health, Newcastle University, Newcastle upon Tyne, UK.
出版信息
BMJ Paediatr Open. 2021 Oct 18;5(1):e001224. doi: 10.1136/bmjpo-2021-001224. eCollection 2021.
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.
简介
I-KID 研究旨在确定新型非 CE 标记婴儿血液透析机——纽卡斯尔婴儿透析超滤系统（NIDUS）的临床疗效、结果和安全性，与英国目前可用的治疗方法进行比较。NIDUS 专门为 0.8 至 8 公斤的小婴儿设计，用于肾脏替代治疗。
方法与分析
临床研究在英国六个中心进行。这是一项使用集群分步楔形设计的随机临床试验。该研究旨在 20 个月内招募 95 名在儿科重症监护病房需要肾脏替代治疗的婴儿。
伦理与传播
在研究设计的所有阶段，都有很高的家长和公众参与度，家长将通过出版物、会议记录和通讯参与研究结果向家长和专业人士的传播。该研究已获得泰恩威尔南研究伦理委员会的伦理许可。
试验注册号
IRAS ID 号：170481MHRA 参考号：CI/2017/0066ISRCTN 编号：13787486CPMS ID 号：36558NHS REC 参考号：16/NE/0008Eudamed 编号：CIV-GB-18-02-023105全文协议第 6.0 版链接：https://fundingawards.nihr.ac.uk/award/14/23/26。
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