title: Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates: Design of a Retrospective Cohort Study.
abstract: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Stead Family Department of Pediatrics, Division of Nephrology, Dialysis and Transplantation, University of Iowa Children's Hospital , Iowa City, IA , USA.
authors.forename: Jennifer G
authors.initials: JG
authors.lastname: Jetton
authors.affiliation: Department of Pediatrics, Division of Neonatology, University of Rochester Medical Center , Rochester, NY , USA.
authors.forename: Ronnie
authors.initials: R
authors.lastname: Guillet
authors.affiliation: Department of Pediatrics, Division of Nephrology, University of Alabama at Birmingham , Birmingham, AL , USA.
authors.forename: David J
authors.initials: DJ
authors.lastname: Askenazi
authors.affiliation: Department of Pediatrics, Division of Nephrology, University of Alabama at Birmingham , Birmingham, AL , USA.
authors.forename: Lynn
authors.initials: L
authors.lastname: Dill
authors.affiliation: Data Management Center, Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center , Cincinnati, OH , USA.
authors.forename: Judd
authors.initials: J
authors.lastname: Jacobs
authors.affiliation: Department of Neonatology, Centenary Hospital for Women and Children, Canberra Hospital, Australian National University Medical School , Canberra, ACT , Australia.
authors.forename: Alison L
authors.initials: AL
authors.lastname: Kent
authors.affiliation: Department of Pediatrics and Communicable Diseases, Division of Nephrology, C.S. Mott Children's Hospital, University of Michigan , Ann Arbor, MI , USA.
authors.forename: David T
authors.initials: DT
authors.lastname: Selewski
authors.affiliation: Department of Pediatrics, Division of Nephrology, Holtz Children's Hospital, University of Miami , Miami, FL , USA.
authors.forename: Carolyn L
authors.initials: CL
authors.lastname: Abitbol
authors.affiliation: Department of Pediatrics, Division of Nephrology, Children's Hospital at Montefiore, Albert Einstein , Bronx, NY , USA.
authors.forename: Fredrick J
authors.initials: FJ
authors.lastname: Kaskel
authors.affiliation: Department of Pediatrics, Division of Neonatology, MetroHealth Medical Center, Case Western Reserve University , Cleveland, OH , USA.
authors.forename: Maroun J
authors.initials: MJ
authors.lastname: Mhanna
authors.affiliation: Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham , Birmingham, AL , USA.
authors.forename: Namasivayam
authors.initials: N
authors.lastname: Ambalavanan
authors.affiliation: Department of Pediatrics, Division of Nephrology, University of Virginia , Charlottesville, VA , USA.
authors.forename: Jennifer R
authors.initials: JR
authors.lastname: Charlton
keywords: AWAKEN; KDIGO; NKC; acute renal failure; database; neonate