@article{d56e178aa6d0486486f1ff9bcd530316,
title = "Assessment of worldwide acute kidney injury epidemiology in neonates: Design of a retrospective cohort study",
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{\texttrademark}) 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.",
keywords = "AWAKEN, Acute renal failure, Database, KDIGO, NKC, Neonate",
author = "{Neonatal Kidney Collaborative} and Jetton, {Jennifer G.} and Ronnie Guillet and Askenazi, {David J.} and Lynn Dill and Judd Jacobs and Kent, {Alison L.} and Selewski, {David T.} and Abitbol, {Carolyn L.} and Kaskel, {Fredrick J.} and Mhanna, {Maroun J.} and Namasivayam Ambalavanan and Charlton, {Jennifer R.} and Arikan, {Ayse Akcan} and Alok Bhutada and Elizabeth Bonachea and Louis Boohaker and Brophy, {Patrick D.} and Chishti, {Aftab S.} and Colaizy, {Tarah T.} and Cole, {F. Sessions} and Carl D'Angio and Davis, {T. Keefe} and Marissa DeFreitas and Joshua Dower and Shahnaz Duara and Jeffery Fletcher and Mamta Fuloria and Jason Gien and Gist, {Katja M.} and Goldstein, {Stuart L.} and Russell Griffin and Hanna, {Mina H.} and Sangeeta Hingorani and Susan Ingraham and Catherine Joseph and Surender Khokhar and Klein, {Jonathan M.} and Deepak Kumar and Kupferman, {Juan C.} and John Mahan and Cherry Mammen and Ayesa Mian and Lawrence Milner and Arwa Nada and Nathan, {Amy T.} and Robin Ohls and Sofia Perazzo and Erin Rademacher and Rupesh Raina and Kimberly Reidy",
note = "Funding Information: The Cincinnati Children{\textquoteright}s Hospital Center for Acute Care Nephrology (SLG, Director) provided funding to create and maintain the AWAKEN Medidata Rave electronic database. CA was supported by the Micah Batchelor Foundation. AAA and CJR were supported by the Section of Pediatric Nephrology, Department of Pediatrics, Texas Children{\textquoteright}s Hospital. DA and NA are supported by the Pediatric and Infant Center for Acute Nephrology (PICAN), which is sponsored by Children{\textquoteright}s of Alabama and the University of Alabama at Birmingham{\textquoteright}s School of Medicine, Department of Pediatrics and Center for Clinical and Translational Science (CCTS) under award number UL1TR00165. PDB, TTC, JGJ, and JMK were supported by the University of Iowa Institute for Clinical and Translational Science. JRC and JRS Funding Information: Conflict of Interest Statement: David Askenazi serves on the speaker board for BAXTER, and the AKI Foundation. Stuart L. Goldstein receives grant funding from Baxter Healthcare and is a consultant for Baxter, Bellco, Inc., Akebia, Inc., AM Pharma, Inc., and Astute Medical. Jonathan M. Klein is a consultant for Draeger Medical. Juan C. Kupferman is on the speaker{\textquoteright}s Bureau and consultant for Alexion Pharmaceuticals. Subrata Sarkar is a consultant for GW Research Ltd, Cambridge, UK. Publisher Copyright: {\textcopyright} 2016 Jetton, Guillet, Askenazi, Dill, Jacobs, Kent, Selewski, Abitbol, Kaskel, Mhanna, Ambalavanan, Charlton and the Neonatal Kidney Collaborative.",
year = "2016",
month = jul,
day = "1",
doi = "10.3389/fped.2016.00068",
language = "English (US)",
volume = "4",
journal = "Frontiers in Pediatrics",
issn = "2296-2360",
publisher = "Frontiers Media S. A.",
number = "JUL",
}
