Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0

Enrolling by invitation

Conditions studied: Acute Kidney Injury, Fluid Overload, Prematurity Complications, Risk Factors, Epidemiology, Chronic Kidney Disease(CKD), Hypertension

In brief

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.

Key facts

Study ID

NCT06823115

Run by

Indiana University

People needed

4000

Starts

2025-03-01

Expected to finish

2026-12-01

Last updated by the study team

2026-04-17

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Age > 14 days at admission
• Congenital heart disease requiring transfer for escalation of CHD care and/or surgery within the first 7 days
• Lethal chromosomal anomalies
• Neonatal mortality <48 hours

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Stanford Children's — Palo Alto, California, United States
• Rady Children's Hospital/UCSD — San Diego, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• Children's National Hospital — Washington D.C., District of Columbia, United States
• Miami Children's / Nichlaus Children's Hospital — Miami, Florida, United States
• Baptist Health South Florida/South Miami Hospital — South Miami, Florida, United States
• Emory Healthcare / Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• SIU — Springfield, Illinois, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Kentucky — Lexington, Kentucky, United States
• University of Louisville — Louisville, Kentucky, United States
• University of Maryland — Baltimore, Maryland, United States
• Johns Hopkins University/Hospital — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Washington University — St Louis, Missouri, United States
• Children's Nebraska — Omaha, Nebraska, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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