Acute Kidney InjuryAWAKEN 2NCT06823115
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
An observational study of Acute Kidney Injury and Fluid Overload, run by Indiana University at 125 sites in 33 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 minutes to 2 weeks
- Conditions the study is for
- Acute Kidney Injury, Fluid Overload, Prematurity Complications
- Type of treatment
- Injection or infusion
- How many people
- 8,000 participants
- Where
- 125 sitesin 33 countries
- Study dates
- 1 Mar 2025to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 minutes to 2 weeks
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
125 sites in 33 countries. Contact the study team or a site near you to ask about taking part.
125 sites in 33 countries
United States53 sites
Akron Children's Hospital
Akron, Ohio, 44308
University of Michigan
Ann Arbor, Michigan, 48109
Emory Healthcare / Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Children's Hospital of Georgia
Augusta, Georgia, 30912
Children's Hospital Colorado
Aurora, Colorado, 80045
University of Maryland
Baltimore, Maryland, 21201
Johns Hopkins University/Hospital
Baltimore, Maryland, 21287
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Boston Children's Hospital
Boston, Massachusetts, 02115
Maimonides Medical Center
Brooklyn, New York, 11219
Golisano Children's Hospital at University of Vermont Health
Burlington, Vermont, 05401
UNC
Chapel Hill, North Carolina, 27514
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22930
Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Nationwide Children's
Columbus, Ohio, 43205
UT Southwestern
Dallas, Texas, 75235
Connecticut Children's Medical Center
Hartford, Connecticut, 06032
Texas Children's Hospital
Houston, Texas, 77030
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Riley Hospital for Children
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
Children's Mercy Hospital
Kansas City, Missouri, 64108
University of Kentucky
Lexington, Kentucky, 40536
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72202
University of Louisville
Louisville, Kentucky, 40202
Texas Tech
Lubbock, Texas, 79415
University of Wisconsin
Madison, Wisconsin, 53792
Miami Children's / Nichlaus Children's Hospital
Miami, Florida, 33155
Medical College of Wisconsin / Children's Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
Yale University
New Haven, Connecticut, 06511
Children's Nebraska
Omaha, Nebraska, 68114
Stanford Children's
Palo Alto, California, 94304
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
OHSU
Portland, Oregon, 97239
Cohen Children's Hospital
Queens, New York, 11040
University of Rochester / Golisano Children's Hospital
Rochester, New York, 14642
Primary Children's Hospital
Salt Lake City, Utah, 84113
Christus Children's Hospital
San Antonio, Texas, 78207
Rady Children's Hospital/UCSD
San Diego, California, 92123
Seattle Children's Hospital / University of Washington
Seattle, Washington, 98105
Baptist Health South Florida/South Miami Hospital
South Miami, Florida, 33176
SIU
Springfield, Illinois, 62702
Washington University
St Louis, Missouri, 63110
Stony Brook Medicine
Stony Brook, New York, 11794
Children's Hospital at Montefiore
The Bronx, New York, 10467
Children's National Hospital
Washington D.C., District of Columbia, 20010
Westchester Medical Center/Maria Fareri Children's Hospital
Westchester, New York, 10595
Wake Forest
Winston-Salem, North Carolina, 27157
Canada8 sites
Alberta Children's Hospital/University of Calgary
Calgary
Stollery Children's Hospital
Edmonton
McMaster Children's Hospital
Hamilton
McGill University
Montreal
Mount Sinai Hospital
Toronto, Ontario
The Hospital for Sick Children
Toronto, Ontario
Sunnybrook Health Sciences Center
Toronto
British Columbia Children's Hospital
Vancouver, British Columbia
Australia6 sites
Canberra Hospital
Canberra
The Royal Children's Hospital Melbourne
Melbourne, Victoria
Royal Women's Hospital
Melbourne
Royal North Shore Hospital
North Sydney
Perth Children's Hospital
Perth
Sydney Children's Hospital Westmead
Sydney
Brazil5 sites
Complexo Hospital de Clinicas da Universidade Federal do Parana (HCUFPR)
Curitiba
Joana de Gusmao Children's Hospital
Florianópolis
Hospital de Clinicas de Porto Alegre
Porto Alegre
Centro Neonatal do Instituto da Criança e do Adolescente do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP)
São Paulo
University of Sao Paulo
São Paulo
Greece5 sites
Aghia Sofia Children's Hospital
Athens
University Hospital of Heraklion
Heraklion
Aristotle University
Thessaloniki
Hippokration General Hospital of Thessaloniki
Thessaloniki
Papageorgiou General Hospital Thessaloniki
Thessaloniki
Portugal5 sites
Hospital Pediatrico de Coimbra, ULS de Coimbra
Coimbra
Hospital Dona Estefania/ULS Sao Jose
Lisbon
Hospital Santa Maria, Unidade Local de Saude de Santa Maria
Lisbon
Centro Materno Infantil de Norte Albino Aroso, Unidade Local de Saude de Santo Antonio
Porto
ULS Sao Joao
Porto
Colombia4 sites
Hospital Occidente de Kennedy
Bogotá
Fundacion Valle del Lili Cali
Cali
Clínica Universitaria Bolivariana
Medellín
Hospital General de Medellin
Medellín
India4 sites
St. John's Medical College Hospital
Bengaluru
Dr. Mehta's Hospitals
Chennai
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow
Christian Medical College
Vellore
Turkey (Türkiye)4 sites
Cukurova University
Adana
Ankara Bilkent City Hospital, Children Hospital
Ankara
Istanbul University
Istanbul
Marmara University Pendik Research and Training Hospital
Istanbul
United Kingdom4 sites
University Hospital Bristol and Weston
Bristol
Liverpool Women's Hospital
Liverpool
Great Ormond Street Hospital
London
Royal Victoria Infirmary
Newcastle upon Tyne
Germany3 sites
University of Cologne
Cologne
Heidelberg University Hospital
Heidelberg
University of Marburg
Marburg
Chile2 sites
Hospital Guillermo Grant Benavente
Concepción
Hospital Clinico Universidad Catolica de Chile
Santiago
Japan2 sites
Kitasato University School of Medicine
Kanagawa
University of the Ryukyus
Okinawa
United Arab Emirates1 site
Al Jalila Children's Specialty Hospital
Dubai
About this study
Official title: 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.
Read the detailed description
AWAKEN 2.0 is a multi-center multi-national retrospective analysis utilizing similar methodology to the AWAKEN study. The investigators will capture information on all infants admitted to participating level 3 and 4 NICUs between January 1-March 31, 2019, to answer specific hypothesis regarding the following three inter-connected but independent specific aims:
Specific Aim 1. Describe prevalence of AKI in a multi-national multi-center retrospective cohort, 5 years after the original AWAKEN study.
- Primary hypothesis: The investigators hypothesize that rates of neonatal AKI are higher than the rate described in the original AWAKEN study.
- Population:
- Inclusion Criteria include all infants admitted to participating NICUs between 1/1/19- 3/31/19 and receiving > 48 hours of IV fluids
- Exclusion Criteria include 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 and/or neonatal mortality <48 hours
- Primary Outcome - Neonatal AKI
- Potential confounders - gestational age, birth weight, 5 minute APGAR score, multiple gestation, significant renal anomalies, site characteristics.
Specific Aim 2. Determine if AKI is independently associated with mortality, length of stay, and discharge serum creatinine (SCr).
- The investigators hypothesize that higher stages of AKI are associated with higher mortality, longer lengths of stay and higher serum creatinine at discharge, even after controlling for confounding factors.
- Populations - Same as Specific Aim 1.
- Primary Exposure - Neonatal AKI definitions (table 3)
- Primary Outcome - Survival
- Secondary outcomes will include: Hospital length of stay, BPD.
- Potential confounders - gestational age, birth weight, 5 minute APGAR score, multiple gestation, significant renal anomalies,
- Exploratory outcomes - recognize that the proposed definition may not be the best definition to predict clinical outcomes. Also recognize that there may be a need to have different definitions for premature infants. The investigators plan to explore how other definitions reported in the literature can predict these outcomes (for example using the 90th % for normative values). In addition, this will have the largest comprehensive database to explore new definitions which could incorporate fluid balance and other factors.
Specific Aim 3. Determine if AKI can predict chronic kidney disease, recurrent AKI and hypertension during early childhood.
- The investigators hypothesize that higher stages of AKI are associated with chronic kidney disease and recurrent AKI during early childhood.
- Population - Same as Specific Aim 1
- Primary Exposure - Neonatal AKI definitions (table 3)
- Primary Outcome - Childhood CKD
- Secondary Outcomes - Childhood hypertension, recurrent AKI and childhood ESRD.
Each participating site will screen all neonates admitted to the NICU during the 3 months of study and capture additional data on those who meet the same inclusion and exclusion criteria as the original cohort. There will be 6 different integrated forms.
- Screening form (all infants)
- Baseline form for included infants (maternal demographic data, admission indication)
- First 14 days form (i.e. urine output, medications and respiratory support)
- Serum creatinine data (all values from date of birth to date of IRB approval)
- Discharge form (discharge diagnoses, medications, follow-up anticipated)
- Follow-up Information (clinically obtained follow-up after discharge)
- Conditions
- Acute Kidney Injury, Fluid Overload, Prematurity Complications, Risk Factors, Epidemiology, Chronic Kidney Disease(CKD)
- Keywords
- acute kidney injury, chronic kidney disease, neonates, prematurity, hypertension
- Medical subject headings
- Acute Kidney Injury, Edema, Renal Insufficiency, Chronic, Hypertension, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months or NICU discharge, whichever comes first
Secondary outcomes (6)
Risk factors for Neonatal AKI
Define the major risk factors associated with neonatal AKI. The investigators will randomly split the cohort into two groups. The investigators will develop a risk factor prediction model with the first group, and test the ability of the model to predict AKI with the second group.
Measured: Up to 6 months or NICU discharge, whichever comes first
Fluid Overload
Fluid overload will be calculated based on daily weights and intake and output values. We will determine how fluid balance during the first few weeks of life relates to biochemical data and clinical outcomes.
Measured: NICU admission through discharge.
Mortality
Determine if the KDIGO AKI definition adapted to neonates can predict mortality. Investigators will also evaluate if other thresholds or proposed AKI definitions can better predict mortality.
Measured: Up to 6 months or NICU discharge, whichever comes first
Chronic Kidney Disease
In infants with available follow-up data clinically obtained, investigators will determine the rates of both clinically diagnosed (by ICD code or note) and laboratory determined Chronic Kidney Disease (using the CKID-U25 eGFR definitions).
Measured: NICU discharge to 5 year follow-up
Hypertension
In infants with available follow-up data clinically obtained, investigators will determine the rates of both clinically diagnosed (by ICD code or note) and value determined hypertension (using AAP Hypertension thresholds)
Measured: NICU discharge to 5 year follow-up
Proteinuria
In infants with available follow-up data clinically obtained, investigators will determine the rates of both clinically diagnosed (by ICD code or note) and laboratory determined proteinuria.
Measured: NICU discharge to 5 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Mar 2025
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Neonatal Kidney Collaborative, Pediatric Nephrology Research Consortium
- Responsible party
- Principal investigator, Michelle Casey Starr, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823115
- Sponsor's protocol ID
- 23847
- Acronym
- AWAKEN 2
- Status last verified
- Oct 2026
- First submitted
- 4 Feb 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0: Towards Expanding Our Understanding of Neonatal Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT06823115
- Acronym / sponsor ID
- AWAKEN 2 / 23847
- Conditions
- Acute Kidney Injury, Fluid Overload, Prematurity Complications, Risk Factors, Epidemiology, Chronic Kidney Disease(CKD)
- Keywords
- acute kidney injury, chronic kidney disease, neonates, prematurity, hypertension
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Neonatal Kidney Collaborative, Pediatric Nephrology Research Consortium
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
AWAKEN 2.0 is a multi-center multi-national retrospective analysis utilizing similar methodology to the AWAKEN study. The investigators will capture information on all infants admitted to participating level 3 and 4 NICUs between January 1-March 31, 2019, to answer specific hypothesis regarding the following three inter-connected but independent specific aims:
Specific Aim 1. Describe prevalence of AKI in a multi-national multi-center retrospective cohort, 5 years after the original AWAKEN study.
- Primary hypothesis: The investigators hypothesize that rates of neonatal AKI are higher than the rate described in the original AWAKEN study.
- Population:
- Inclusion Criteria include all infants admitted to participating NICUs between 1/1/19- 3/31/19 and receiving > 48 hours of IV fluids
- Exclusion Criteria include 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 and/or neonatal mortality <48 hours
- Primary Outcome - Neonatal AKI
- Potential confounders - gestational age, birth weight, 5 minute APGAR score, multiple gestation, significant renal anomalies, site characteristics.
Specific Aim 2. Determine if AKI is independently associated with mortality, length of stay, and discharge serum creatinine (SCr).
- The investigators hypothesize that higher stages of AKI are associated with higher mortality, longer lengths of stay and higher serum creatinine at discharge, even after controlling for confounding factors.
- Populations - Same as Specific Aim 1.
- Primary Exposure - Neonatal AKI definitions (table 3)
- Primary Outcome - Survival
- Secondary outcomes will include: Hospital length of stay, BPD.
- Potential confounders - gestational age, birth weight, 5 minute APGAR score, multiple gestation, significant renal anomalies,
- Exploratory outcomes - recognize that the proposed definition may not be the best definition to predict clinical outcomes. Also recognize that there may be a need to have different definitions for premature infants. The investigators plan to explore how other definitions reported in the literature can predict these outcomes (for example using the 90th % for normative values). In addition, this will have the largest comprehensive database to explore new definitions which could incorporate fluid balance and other factors.
Specific Aim 3. Determine if AKI can predict chronic kidney disease, recurrent AKI and hypertension during early childhood.
- The investigators hypothesize that higher stages of AKI are associated with chronic kidney disease and recurrent AKI during early childhood.
- Population - Same as Specific Aim 1
- Primary Exposure - Neonatal AKI definitions (table 3)
- Primary Outcome - Childhood CKD
- Secondary Outcomes - Childhood hypertension, recurrent AKI and childhood ESRD.
Each participating site will screen all neonates admitted to the NICU during the 3 months of study and capture additional data on those who meet the same inclusion and exclusion criteria as the original cohort. There will be 6 different integrated forms.
- Screening form (all infants)
- Baseline form for included infants (maternal demographic data, admission indication)
- First 14 days form (i.e. urine output, medications and respiratory support)
- Serum creatinine data (all values from date of birth to date of IRB approval)
- Discharge form (discharge diagnoses, medications, follow-up anticipated)
- Follow-up Information (clinically obtained follow-up after discharge)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 0 minutes to 2 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neonatal Acute Kidney Injury
Time frame: Up to 6 months or NICU discharge, whichever comes first
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.
6 secondary outcomes
Risk factors for Neonatal AKI
Time frame: Up to 6 months or NICU discharge, whichever comes first
Fluid Overload
Time frame: NICU admission through discharge.
Mortality
Time frame: Up to 6 months or NICU discharge, whichever comes first
Chronic Kidney Disease
Time frame: NICU discharge to 5 year follow-up
Hypertension
Time frame: NICU discharge to 5 year follow-up
Proteinuria
Time frame: NICU discharge to 5 year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
125 sites in 33 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Fluid Overload, run by Indiana University at 125 sites in 33 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 125 sites in United States, Canada, Australia, Brazil, Greece and 28 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Acute Kidney Injury (time frame: Up to 6 months or NICU discharge, whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.