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ENROLLING BY INVITATION
NCT06823115

Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0

Sponsor: Indiana University

View on ClinicalTrials.gov

Summary

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.

Official title: Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0: Towards Expanding Our Understanding of Neonatal Acute Kidney Injury

Key Details

Gender

All

Age Range

0 Minutes - 2 Weeks

Study Type

OBSERVATIONAL

Enrollment

4000

Start Date

2025-03-01

Completion Date

2026-12

Last Updated

2026-04-17

Healthy Volunteers

No

Locations (87)

University of Alabama at Birmingham

Birmingham, Alabama, United States

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

Maimonides Medical Center

Brooklyn, New York, United States

Cohen Children's Hospital

Queens, New York, United States

University of Rochester / Golisano Children's Hospital

Rochester, New York, United States

Stony Brook Medicine

Stony Brook, New York, United States

Children's Hospital at Montefiore

The Bronx, New York, United States

Westchester Medical Center/Maria Fareri Children's Hospital

Westchester, New York, United States

UNC

Chapel Hill, North Carolina, United States

Wake Forest

Winston-Salem, North Carolina, United States

Akron Children's Hospital

Akron, Ohio, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Nationwide Children's

Columbus, Ohio, United States

OHSU

Portland, Oregon, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

UT Southwestern

Dallas, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

Texas Tech

Lubbock, Texas, United States

Christus Children's Hospital

San Antonio, Texas, United States

Primary Children's Hospital

Salt Lake City, Utah, United States

Golisano Children's Hospital at University of Vermont Health

Burlington, Vermont, United States

University of Virginia

Charlottesville, Virginia, United States

Seattle Children's Hospital / University of Washington

Seattle, Washington, United States

University of Wisconsin

Madison, Wisconsin, United States

Medical College of Wisconsin / Children's Wisconsin

Milwaukee, Wisconsin, United States

The Royal Children's Hospital Melbourne

Melbourne, Victoria, Australia

Perth Children's Hospital

Perth, Australia

Joana de Gusmao Children's Hospital

Florianópolis, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Brazil

The Hospital for Sick Children

Toronto, Ontario, Canada

Alberta Children's Hospital/University of Calgary

Calgary, Canada

Stollery Children's Hospital

Edmonton, Canada

McMaster Children's Hospital

Hamilton, Canada

McGill University

Montreal, Canada

Mount Sinai Hospital

Toronto, Canada

Sunnybrook Health Sciences Center

Toronto, Canada

Hospital Occidente de Kennedy

Bogotá, Colombia

Fundacion Valle del Lili Cali

Cali, Colombia

Clínica Universitaria Bolivariana

Medellín, Colombia

Institute for the Care of Mother and Child

Prague, Czechia

University of Cologne

Cologne, Germany

Aghia Sofia Children's Hospital

Athens, Greece

University Hospital of Heraklion

Heraklion, Greece

Aristotle University

Thessaloniki, Greece

Hippokration General Hospital of Thessaloniki

Thessaloniki, Greece

University of Szeged Children's Hospital

Szeged, Hungary

St. John's Medical College Hospital

Bengaluru, India

Dr. Mehta's Hospitals

Chennai, India

Christian Medical College

Vellore, India

Centro de Alta Especialidad del Estado de Veracruz

Veracruz, Mexico

Amalia Children's Hospital Radboudumc

Nijmegen, Netherlands

University of Ibadan

Ibadan, Nigeria

Hospital Santa Maria, Unidade Local de Saude de Santa Maria

Lisbon, Portugal

Centro Materno Infantil de Norte Albino Aroso, Unidade Local de Saude de Santo Antonio

Porto, Portugal

ULS Sao Joan

Porto, Portugal

University Medical Centre Ljubljana

Ljubljana, Slovenia

Puerta del Mar University Hospital

Cadiz, Spain

Cukurova University

Adana, Turkey (Türkiye)

Ankara Bilkent City Hospital, Children Hospital

Ankara, Turkey (Türkiye)

Marmara University Pendik Research and Training Hospital

Istanbul, Turkey (Türkiye)

St Francis Nsambya

Kampala, Uganda

Bukovinian State Medical University

Chernivtsi, Ukraine