Studies kidney injury in newborns admitted to intensive care worldwide
Looks back at kidney injury in newborns cared for in intensive care units.
Plain-language title generated from the registry record
Registry title: Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Key facts
- Where
- Akron, Ann Arbor, Atlanta, Augusta, Aurora, Baltimore, Birmingham, Boston, Brooklyn, Burlington, Chapel Hill, Charleston, Charlottesville, Chicago, Cincinnati, Columbus, Dallas, Hartford, Houston, Indianapolis, Iowa City, Kansas City, Lexington, Little Rock, Louisville, Lubbock, Madison, Miami, Milwaukee, Minneapolis, Nashville, New Haven, Omaha, Palo Alto, Philadelphia, Pittsburgh, Portland, Queens, Rochester, Salt Lake City, San Antonio, San Diego, Seattle, South Miami, Springfield, St Louis, Stony Brook, The Bronx, Washington D.C., Westchester, and Winston-Salem, United StatesSee the 53 sites
Where in United States
- Akron Children's HospitalAkron, United StatesNo longer taking part
- University of MichiganAnn Arbor, United StatesNo longer taking part
- Emory Healthcare / Children's Healthcare of AtlantaAtlanta, United StatesNo longer taking part
- Children's Hospital of GeorgiaAugusta, United StatesNo longer taking part
- Children's Hospital ColoradoAurora, United StatesNo longer taking part
- Johns Hopkins University HospitalBaltimore, United StatesNo longer taking part
- University of MarylandBaltimore, United StatesNo longer taking part
- University of Alabama at BirminghamBirmingham, United StatesNo longer taking part
- Boston Children's HospitalBoston, United StatesNo longer taking part
- Maimonides Medical CenterBrooklyn, United StatesNo longer taking part
- Golisano Children's Hospital at University of Vermont HealthBurlington, United StatesNo longer taking part
- UNCChapel Hill, United StatesNo longer taking part
- Medical University of South CarolinaCharleston, United StatesNo longer taking part
- University of VirginiaCharlottesville, United StatesNo longer taking part
- Lurie Children's Hospital of ChicagoChicago, United StatesNo longer taking part
- Cincinnati Children's HospitalCincinnati, United StatesNo longer taking part
- Nationwide Children'sColumbus, United StatesNo longer taking part
- UT SouthwesternDallas, United StatesNo longer taking part
- Connecticut Children's Medical CenterHartford, United StatesNo longer taking part
- Texas Children's HospitalHouston, United StatesNo longer taking part
- Indiana University School of MedicineIndianapolis, United StatesNo longer taking part
- Riley Hospital for ChildrenIndianapolis, United StatesNo longer taking part
- University of IowaIowa City, United StatesNo longer taking part
- Children's Mercy HospitalKansas City, United StatesNo longer taking part
- University of KentuckyLexington, United StatesNo longer taking part
- University of Arkansas for Medical SciencesLittle Rock, United StatesNo longer taking part
- University of LouisvilleLouisville, United StatesNo longer taking part
- Texas TechLubbock, United StatesNo longer taking part
- University of WisconsinMadison, United StatesNo longer taking part
- Miami Children's / Nichlaus Children's HospitalMiami, United StatesNo longer taking part
- Medical College of Wisconsin, Children's WisconsinMilwaukee, United StatesNo longer taking part
- University of MinnesotaMinneapolis, United StatesNo longer taking part
- Monroe Carell Jr. Children's Hospital at VanderbiltNashville, United StatesNo longer taking part
- Yale UniversityNew Haven, United StatesNo longer taking part
- Children's NebraskaOmaha, United StatesNo longer taking part
- Stanford Children'sPalo Alto, United StatesNo longer taking part
- Children's Hospital of PhiladelphiaPhiladelphia, United StatesNo longer taking part
- University of Pittsburgh Medical CenterPittsburgh, United StatesNo longer taking part
- OHSUPortland, United StatesNo longer taking part
- Cohen Children's HospitalQueens, United StatesNo longer taking part
- University of Rochester / Golisano Children's HospitalRochester, United StatesNo longer taking part
- Primary Children's HospitalSalt Lake City, United StatesNo longer taking part
- Christus Children's HospitalSan Antonio, United StatesNo longer taking part
- Rady Children's Hospital/UCSDSan Diego, United StatesNo longer taking part
- Seattle Children's Hospital; University of WashingtonSeattle, United StatesNo longer taking part
- Baptist Health South Florida/South Miami HospitalSouth Miami, United StatesNo longer taking part
- SIUSpringfield, United StatesNo longer taking part
- Washington UniversitySt Louis, United StatesNo longer taking part
- Stony Brook MedicineStony Brook, United StatesNo longer taking part
- Children's Hospital at MontefioreThe Bronx, United StatesNo longer taking part
- Children's National HospitalWashington D.C., United StatesNo longer taking part
- Westchester Medical Center/Maria Fareri Children's HospitalWestchester, United StatesNo longer taking part
- Wake ForestWinston-Salem, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Indiana University
- Trial code
- NCT06823115
- Record updated
- 28 October 2026
- Original description
There is a growing focus on short- and long-term kidney health in neonates, including those with acute kidney injury (AKI). AKI occurs commonly in the Neonatal Intensive Care Unit (NICU) and is associated with adverse outcomes. In addition to poor outcomes during the hospitalization, infants discharged from the NICU may have an increased burden of kidney disease during childhood. Studies of long-term kidney function in children born prematurely show a fourfold increase in chronic kidney disease (CKD) by adolescence and into adulthood.Read full original descriptionShow less
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0: Towards Expanding Our Understanding of Neonatal Acute Kidney Injury
There is a growing focus on short- and long-term kidney health in neonates, including those with acute kidney injury (AKI). AKI occurs commonly in the Neonatal Intensive Care Unit (NICU) and is associated with adverse outcomes. In addition to poor outcomes during the hospitalization, infants discharged from the NICU may have an increased burden of kidney disease during childhood. Studies of long-term kidney function in children born prematurely show a fourfold increase in chronic kidney disease (CKD) by adolescence and into adulthood.
Despite the landmark findings of the Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates (AWAKEN) study, the limitations of this study are notable. First, the AWAKEN study enrolled infants admitted in 2014, making the data now over 10 years old. Much has changed in neonatal practice (e.g. increased AKI awareness, treatment strategies). Secondly, the findings of the AWAKEN study were geographically limited. While the AWAKEN study was multi-national and multi-center, it represented only 24 centers (22 from North America, 1 from India and 1 from Australia). Finally, information collected from AWAKEN ended at hospital discharge.
The investigators seek to leverage the strength of the Neonatal Kidney Collaborative along with other organizations and collaboratives interested in neonatal kidney health to address these gaps. Therefore, the investigators are conducting a second, modified iteration of this study entitled "AWAKEN 2.0". AWAKEN 2.0 will be a multi-center multi-national retrospective analysis utilizing similar methodology to the AWAKEN study.
Inclusion: All infants born or admitted to a participating level 3 or 4 NICU between 1/1/19- 3/31/19 will be screened; Infants who received intravenous fluids for > 48 hours will be eligible.
Exclusion: Congenital heart disease requiring transfer for escalation of CHD care and/or surgery within the first 7 days; Age > 14 days at admission; Lethal chromosomal anomalies; Neonatal mortality <48 hours.