AUTHOR=Jetton Jennifer G. , Guillet Ronnie , Askenazi David J. , Dill Lynn , Jacobs Judd , Kent Alison L. , Selewski David T. , Abitbol Carolyn L. , Kaskel Fredrick J. , Mhanna Maroun J. , Ambalavanan Namasivayam , Charlton Jennifer R. , the Neonatal Kidney Collaborative , Akcan Arikan Ayse , Bhutada Alok , Bonachea Elizabeth , Boohaker Louis , Brophy Patrick D. , Chishti Aftab S. , Colaizy Tarah T. , Cole F. Sessions , D’Angio Carl , Davis T. Keefe , DeFreitas Marissa , Dower Joshua , Duara Shahnaz , Fletcher Jeffery , Fuloria Mamta , Gien Jason , Gist Katja M. , Goldstein Stuart L. , Griffin Russell , Hanna Mina H. , Hingorani Sangeeta , Ingraham Susan , Joseph Catherine , Khokhar Surender , Klein Jonathan M. , Kumar Deepak , Kupferman Juan C. , Mahan John , Mammen Cherry , Mian Ayesa , Milner Lawrence , Nada Arwa , Nathan Amy T. , Ohls Robin , Perazzo Sofia , Rademacher Erin , Raina Rupesh , Rastogi Shantanu , Ray Patricio E. , Reidy Kimberly , Revenis Mary , Rhee Christopher J. , Rohatgi Smriti , Sarkar Subrata , Sethi Sidharth Kumar , Smith Alexandra , Soranno Danielle E. , Sridhar Shanthy , Staples Amy , Starr Michelle , Swanson Jonathan R. , Synnes Anne , Wazir Sanjay , Wintermark Pia , Wong Craig S. , Woroniecki Robert , Zappitelli Michael TITLE=Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates: Design of a Retrospective Cohort Study JOURNAL=Frontiers in Pediatrics VOLUME=4 YEAR=2016 URL=https://www.frontiersin.org/journals/pediatrics/articles/10.3389/fped.2016.00068 DOI=10.3389/fped.2016.00068 ISSN=2296-2360 ABSTRACT=Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Discussion

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.