Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Public ClinicalTrials.gov record NCT06823115. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0: Towards Expanding Our Understanding of Neonatal Acute Kidney Injury
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06823115
- Recruitment status
- Enrolling by invitation
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 4,000 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 0 Minutes to 2 Weeks
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 1, 2025 (Actual)
- Primary completion
- Jan 2027 (Estimated)
- Completion
- Jun 2027 (Estimated)
- Last update posted
- Sep 4, 2026
2025 – 2027
United States locations
- U.S. sites
- 50
- U.S. states
- 31
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72202 | — |
| Stanford Children's | Palo Alto | California | 94304 | — |
| Rady Children's Hospital/UCSD | San Diego | California | 92123 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Yale University | New Haven | Connecticut | 06511 | — |
| Children's National Hospital | Washington D.C. | District of Columbia | 20010 | — |
| Miami Children's / Nichlaus Children's Hospital | Miami | Florida | 33155 | — |
| Baptist Health South Florida/South Miami Hospital | South Miami | Florida | 33176 | — |
| Emory Healthcare / Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | — |
| Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| SIU | Springfield | Illinois | 62702 | — |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| University of Kentucky | Lexington | Kentucky | 40536 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| Johns Hopkins University/Hospital | Baltimore | Maryland | 21287 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Children's Nebraska | Omaha | Nebraska | 68114 | — |
| Maimonides Medical Center | Brooklyn | New York | 11219 | — |
| Cohen Children's Hospital | Queens | New York | 11040 | — |
| University of Rochester / Golisano Children's Hospital | Rochester | New York | 14642 | — |
| Stony Brook Medicine | Stony Brook | New York | 11794 | — |
| Children's Hospital at Montefiore | The Bronx | New York | 10467 | — |
| Westchester Medical Center/Maria Fareri Children's Hospital | Westchester | New York | 10595 | — |
| UNC | Chapel Hill | North Carolina | 27514 | — |
| Wake Forest | Winston-Salem | North Carolina | 27157 | — |
| Akron Children's Hospital | Akron | Ohio | 44308 | — |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | — |
| Nationwide Children's | Columbus | Ohio | 43205 | — |
| OHSU | Portland | Oregon | 97239 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | — |
| UT Southwestern | Dallas | Texas | 75235 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| Texas Tech | Lubbock | Texas | 79415 | — |
| Christus Children's Hospital | San Antonio | Texas | 78207 | — |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | — |
| Golisano Children's Hospital at University of Vermont Health | Burlington | Vermont | 05401 | — |
| University of Virginia | Charlottesville | Virginia | 22930 | — |
| Seattle Children's Hospital / University of Washington | Seattle | Washington | 98105 | — |
| University of Wisconsin | Madison | Wisconsin | 53792 | — |
| Medical College of Wisconsin / Children's Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 37 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06823115, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 4, 2026 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06823115 live on ClinicalTrials.gov.