Studies kidney injury in newborns admitted to intensive care worldwide
Looks back at kidney injury in newborns cared for in intensive care units.
Plain-language title generated from the registry record
Registry title: Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Key facts
- Where
- Calgary, Edmonton, Hamilton, Montreal, Toronto, and Vancouver, CanadaSee the 8 sites
Where in Canada
- Alberta Children's Hospital - University of CalgaryCalgary, CanadaNo longer taking part
- Stollery Children'S HospitalEdmonton, CanadaNo longer taking part
- McMaster Children's HospitalHamilton, CanadaNo longer taking part
- McGill UniversityMontreal, CanadaNo longer taking part
- Mount Sinai HospitalToronto, CanadaNo longer taking part
- Sunnybrook Health Sciences CenterToronto, CanadaNo longer taking part
- The Hospital for Sick ChildrenToronto, CanadaNo longer taking part
- British Columbia Children's HospitalVancouver, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Indiana University
- Trial code
- NCT06823115
- Record updated
- 28 October 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Congenital heart disease requiring transfer for escalation of CHD care and/or surgery within the first 7 days; Age > 14 days at admission; Lethal chromosomal anomalies; Neonatal mortality <48 hours.