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By invitation only NCT06823115

Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0

Conditions: Acute Kidney Injury Fluid Overload Prematurity Complications Risk Factors Epidemiology Chronic Kidney Disease(CKD) Hypertension

Sponsor: Indiana University

trial.available_in: БГ
Overview
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.
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. 1. Primary hypothesis: The investigators hypothesize that rates of neonatal AKI are higher than the rate described in the original AWAKEN study. 2. Population: 1. Inclusion Criteria include all infants admitted to participating NICUs between 1/1/19- 3/31/19 and receiving \> 48 hours of IV fluids 2. 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 3. Primary Outcome - Neonatal AKI 4. 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). 1. 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. 2. Populations - Same as Specific Aim 1. 3. Primary Exposure - Neonatal AKI definitions (table 3) 4. Primary Outcome - Survival 5. Secondary outcomes will include: Hospital length of stay, BPD. 6. Potential confounders - gestational age, birth weight, 5 minute APGAR score, multiple gestation, significant renal anomalies, 7. 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. 1. The investigators hypothesize that higher stages of AKI are associated with chronic kidney disease and recurrent AKI during early childhood. 2. Population - Same as Specific Aim 1 3. Primary Exposure - Neonatal AKI definitions (table 3) 4. Primary Outcome - Childhood CKD 5. 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
Who can participate
Inclusion Criteria: 1. All infants born or admitted to a participating level 3 or 4 NICU between 1/1/19- 3/31/19 will be screened. 2. Infants who received intravenous fluids for \> 48 hours will be eligible. 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
Locations 19
Australia (1)
The Royal Children's Hospital Melbourne
Melbourne , Victoria
Brazil (1)
Joana de Gusmao Children's Hospital
Florianópolis
Canada (1)
The Hospital for Sick Children
Toronto , Ontario
Colombia (1)
Hospital Occidente de Kennedy
Bogotá
Czech Republic (1)
Institute for the Care of Mother and Child
Prague
Germany (1)
University of Cologne
Cologne
Greece (1)
Aghia Sofia Children's Hospital
Athens
Hungary (1)
University of Szeged Children's Hospital
Szeged
India (1)
St. John's Medical College Hospital
Bengaluru
Mexico (1)
Centro de Alta Especialidad del Estado de Veracruz
Veracruz
Netherlands (1)
Amalia Children's Hospital Radboudumc
Nijmegen
Nigeria (1)
University of Ibadan
Ibadan
Portugal (1)
Hospital Santa Maria, Unidade Local de Saude de Santa Maria
Lisbon
Slovenia (1)
University Medical Centre Ljubljana
Ljubljana
Spain (1)
Puerta del Mar University Hospital
Cadiz
Turkey (1)
Cukurova University
Adana
Uganda (1)
St Francis Nsambya
Kampala
Ukraine (1)
Bukovinian State Medical University
Chernivtsi
United States (1)
University of Alabama at Birmingham
Birmingham , Alabama
Technical details
Status
By invitation only
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
0 Minutes
Maximum age
2 Weeks
Healthy volunteers
No
Start date
01.03.2025
Completion date
01.12.2026
Registry ID
NCT06823115
Source
anzctr
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