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| Name | Class |
|---|---|
| Neonatal Kidney Collaborative | UNKNOWN |
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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.
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:
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).
Specific Aim 3. Determine if AKI can predict chronic kidney disease, recurrent AKI and hypertension during early childhood.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neonates at Risk of Kidney Disease | Inclusion Criteria
Exclusion Criteria
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 6 months or NICU discharge, whichever comes first |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of Arkansas for Medical Sciences |
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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| 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. | 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. | 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). | 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) | 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. | NICU discharge to 5 year follow-up |
| 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 |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D004487 | Edema |
| D051436 | Renal Insufficiency, Chronic |
| D006973 | Hypertension |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
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