Stead Family Department of Pediatrics, Division of Nephrology, Dialysis and Transplantation, University of Iowa Children's Hospital , Iowa City, IA , USA.
Department of Pediatrics, Division of Neonatology, University of Rochester Medical Center , Rochester, NY , USA.
Front Pediatr. 2016 Jul 19;4:68. doi: 10.3389/fped.2016.00068. eCollection 2016.
Acute kidney injury (AKI) affects ~30% of hospitalized neonates. Critical to advancing our understanding of neonatal AKI is collaborative research among neonatologists and nephrologists. The Neonatal Kidney Collaborative (NKC) is an international, multidisciplinary group dedicated to investigating neonatal AKI. The AWAKEN study (Assessment of Worldwide Acute Kidney injury Epidemiology in Neonates) was designed to describe the epidemiology of neonatal AKI, validate the definition of neonatal AKI, identify primary risk factors for neonatal AKI, and investigate the contribution of fluid management to AKI events and short-term outcomes.
The NKC was established with at least one pediatric nephrologist and neonatologist from 24 institutions in 4 countries (USA, Canada, Australia, and India). A Steering Committee and four subcommittees were created. The database subcommittee oversaw the development of the web-based database (MediData Rave™) that captured all NICU admissions from 1/1/14 to 3/31/14. Inclusion and exclusion criteria were applied to eliminate neonates with a low likelihood of AKI. Data collection included: (1) baseline demographic information; (2) daily physiologic parameters and care received during the first week of life; (3) weekly "snapshots"; (4) discharge information including growth parameters, final diagnoses, discharge medications, and need for renal replacement therapy; and (5) all serum creatinine values.
AWAKEN was proposed as human subjects research. The study design allowed for a waiver of informed consent/parental permission. NKC investigators will disseminate data through peer-reviewed publications and educational conferences.
The purpose of this publication is to describe the formation of the NKC, the establishment of the AWAKEN cohort and database, future directions, and a few "lessons learned." The AWAKEN database includes ~325 unique variables and >4 million discrete data points. AWAKEN will be the largest, most inclusive neonatal AKI study to date. In addition to validating the neonatal AKI definition and identifying risk factors for AKI, this study will uncover variations in practice patterns related to fluid provision, renal function monitoring, and involvement of pediatric nephrologists during hospitalization. The AWAKEN study will position the NKC to achieve the long-term goal of improving the lives, health, and well-being of newborns at risk for kidney disease.
急性肾损伤（AKI）影响了约 30%的住院新生儿。为了深入了解新生儿 AKI，关键在于新生儿科医生和肾脏病学家之间的合作研究。新生儿肾脏协作组（NKC）是一个国际性的多学科组织，致力于研究新生儿 AKI。AWAKEN 研究（评估全世界新生儿急性肾损伤的流行病学）旨在描述新生儿 AKI 的流行病学，验证新生儿 AKI 的定义，确定新生儿 AKI 的主要危险因素，并研究液体管理对 AKI 事件和短期结局的影响。
NKC 由来自 4 个国家（美国、加拿大、澳大利亚和印度）的 24 个机构的至少一名儿科肾脏病学家和新生儿科医生组成。成立了一个指导委员会和四个小组委员会。数据库小组委员会负责开发基于网络的数据库（MediData Rave™），该数据库收录了 2014 年 1 月 1 日至 3 月 31 日期间所有新生儿重症监护病房的入院情况。应用纳入和排除标准以排除 AKI 可能性较低的新生儿。数据收集包括：（1）基线人口统计学信息；（2）生命第一周的日常生理参数和护理情况；（3）每周“快照”；（4）出院信息，包括生长参数、最终诊断、出院药物治疗和肾脏替代治疗的需求；（5）所有血清肌酐值。
AWAKEN 被提议作为人体研究。研究设计允许免除知情同意/家长同意。NKC 调查人员将通过同行评审的出版物和教育会议传播数据。
本出版物的目的是描述 NKC 的形成、AWAKEN 队列和数据库的建立、未来方向以及一些“经验教训”。AWAKEN 数据库包括约 325 个独特变量和超过 400 万条离散数据点。AWAKEN 将是迄今为止最大、最全面的新生儿 AKI 研究。除了验证新生儿 AKI 定义和确定 AKI 的危险因素外，该研究还将揭示与液体供应、肾功能监测以及住院期间儿科肾脏病医生参与相关的实践模式差异。AWAKEN 研究将使 NKC 能够实现改善患有肾脏疾病风险的新生儿的生活、健康和福祉的长期目标。
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