Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
AWAKEN 2
1 other identifier
observational
4,000
19 countries
87
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2025
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2025
CompletedFirst Posted
Study publicly available on registry
February 12, 2025
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
April 17, 2026
April 1, 2026
1.3 years
February 4, 2025
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neonatal Acute Kidney Injury
The investigators will evaluate the rate of neonatal AKI among infants that meet inclusion criteria across all sites. Neonatal Acute Kidney Injury will be defined by the standard neonatal definitions, including serum creatinine values and urine output (when available). Furthermore, investigators will examine if different thresholds or definitions of AKI will better predict outcomes.
Up to 6 months or NICU discharge, whichever comes first
Secondary Outcomes (6)
Risk factors for Neonatal AKI
Up to 6 months or NICU discharge, whichever comes first
Fluid Overload
NICU admission through discharge.
Mortality
Up to 6 months or NICU discharge, whichever comes first
Chronic Kidney Disease
NICU discharge to 5 year follow-up
Hypertension
NICU discharge to 5 year follow-up
- +1 more secondary outcomes
Study Arms (1)
Neonates at Risk of Kidney Disease
Inclusion Criteria 1. Admitted to participating NICUs between 1/1/19- 3/31/19 2. \> 48 hours of IV fluids Exclusion Criteria 1. Age \> 14 days at admission 2. Congenital heart disease requiring transfer for escalation of CHD care and/or surgery within the first 7 days 3. Lethal chromosomal anomalies 4. Neonatal mortality \<48 hours
Eligibility Criteria
The investigators will conduct a multi-center retrospective cohort study. All infants admitted to the NICU between January 1, 2019 and March 31, 2019 will be screened for the study.The investigators will enroll eligible infants who meet inclusion and exclusion criteria at each center for 3 consecutive months. Based on average admissions for 2018 at our centers who meet inclusion and exclusion criteria, it is estimated that it can enroll approximately 4000 infants during this time.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- Neonatal Kidney Collaborativecollaborator
Study Sites (87)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72202, United States
Stanford Children's
Palo Alto, California, 94304, United States
Rady Children's Hospital/UCSD
San Diego, California, 92123, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Yale University
New Haven, Connecticut, 06511, United States
Children's National Hospital
Washington D.C., District of Columbia, 20010, United States
Miami Children's / Nichlaus Children's Hospital
Miami, Florida, 33155, United States
Baptist Health South Florida/South Miami Hospital
South Miami, Florida, 33176, United States
Emory Healthcare / Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
SIU
Springfield, Illinois, 62702, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
University of Louisville
Louisville, Kentucky, 40202, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Johns Hopkins University/Hospital
Baltimore, Maryland, 21287, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Washington University
St Louis, Missouri, 63110, United States
Children's Nebraska
Omaha, Nebraska, 68114, United States
Maimonides Medical Center
Brooklyn, New York, 11219, United States
Cohen Children's Hospital
Queens, New York, 11040, United States
University of Rochester / Golisano Children's Hospital
Rochester, New York, 14642, United States
Stony Brook Medicine
Stony Brook, New York, 11794, United States
Children's Hospital at Montefiore
The Bronx, New York, 10467, United States
Westchester Medical Center/Maria Fareri Children's Hospital
Westchester, New York, 10595, United States
UNC
Chapel Hill, North Carolina, 27514, United States
Wake Forest
Winston-Salem, North Carolina, 27157, United States
Akron Children's Hospital
Akron, Ohio, 44308, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
Nationwide Children's
Columbus, Ohio, 43205, United States
OHSU
Portland, Oregon, 97239, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232, United States
UT Southwestern
Dallas, Texas, 75235, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Texas Tech
Lubbock, Texas, 79415, United States
Christus Children's Hospital
San Antonio, Texas, 78207, United States
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
Golisano Children's Hospital at University of Vermont Health
Burlington, Vermont, 05401, United States
University of Virginia
Charlottesville, Virginia, 22930, United States
Seattle Children's Hospital / University of Washington
Seattle, Washington, 98105, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin / Children's Wisconsin
Milwaukee, Wisconsin, 53226, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics
Study Record Dates
First Submitted
February 4, 2025
First Posted
February 12, 2025
Study Start
March 1, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
As a retrospective study and based on terms of the data sharing agreements between sites, individual patient level data will not be made available. Investigators that have questions that may be answered by the data will be able to present proposal to request secondary data analyses to be conducted on de-identified data.