Review Summarizes Global Findings From the AWAKEN Neonatal AKI Study
November 13, 2025
Tara Beck, DO, a dual fellow in pediatric nephrology and neonatal-perinatal medicine at UPMC Children’s Hospital of Pittsburgh, coauthored a review article published in Current Opinion in Pediatrics summarizing results from the Assessment of Worldwide Acute Kidney Epidemiology in Neonates (AWAKEN) study. The review by Dr. Beck and colleagues covers the origins of the AWAKEN study and the research conducted to date on neonatal acute kidney injury (AKI) based on its data.
About the AWAKEN Study
The AWAKEN study and data registry was created in 2014 by the Neonatal Kidney Collaborative. AWAKEN was designed to address the long-standing lack of large-scale, prospectively collected data on the incidence, risk factors, morbidities, and other outcomes of critically ill neonates who experience an AKI. Before the AWAKEN registry was created, the understanding of AKI in neonates was limited to small, single-center retrospective studies. Since its creation, AWAKEN has become the largest multicenter prospective database of neonatal AKI outcomes. The study tracked data on 2,022 neonates from 24 neonatal intensive care units (NICU) in multiple countries.
“The AWAKEN study provided the field the first large-scale, prospective, standardized look at how AKI develops and progresses in neonates across a range of gestational ages,” Dr. Beck says. “Data from the AWAKEN study has helped to transform what we know about acute kidney injury in newborns.”
Review Highlights at a Glance
Incidence and Outcomes of Neonatal AKI
Within the AWAKEN cohort, AKI occurred in approximately 30% of neonates. The rates of AKI were highest for those born before 29 weeks of gestation and in those of 36 weeks or more gestation. This finding suggests that there are distinct developmental and physiologic mechanisms of susceptibility at play at different ages.
It is likely not surprising that neonates who developed AKI experienced decidedly worse outcomes than those in the NICU who did not experience an AKI. Rates of mortality in the AKI cohort were significantly higher compared to newborns without AKI. Hospitalization length of stay was longer for neonates with AKI even when adjusted for gestational age and illness severity. Recurrent AKI was reported in close to 20% of neonates who experienced a first AKI. AWAKEN also showed that documentation of AKI in the medical record was rare, appearing in only about 13% of cases. These and other findings highlight the clinical impact of AKI on newborns in the NICU and persistent gaps in its recognition and follow-up.
“The AWAKEN study reinforces that kidney injury in the NICU is common and clinically meaningful,” Dr. Beck says. “It affects survival, recovery, and the course of other critical illnesses in the immediate setting to say nothing about the long term effects of AKI related to the development of chronic kidney disease and renal failure.”
Risk Factors and Contributing Conditions
The review from Dr. Beck and colleagues provides an overview of the risk factors that were found to increase vulnerability to AKI in the AWAKEN cohort. Most notably, these risk factors include exposure to nephrotoxic medications, hemodynamic instability, and the presence of sepsis and necrotizing enterocolitis. Data from AWAKEN also show that low serum albumin and hemoglobin levels, as well as positive fluid balance, were associated with higher AKI risk. Dysnatremia was found to be a marker for increased mortality.
“One of the most actionable findings from AWAKEN is how modifiable some of these risks are,” Dr. Beck says. “By monitoring fluid status and reducing unnecessary exposure to known nephrotoxic agents, we may be able to meaningfully reduce the incidence of AKI in neonatal populations.”
Multi-Organ Implications and Preventive Strategies
In addition to kidney-specific outcomes, the AWAKEN study has provided important data highlighting the connection between AKI and dysfunction in other organ systems. Associations were observed between AKI and bronchopulmonary dysplasia, intraventricular hemorrhage, patent ductus arteriosus, and neonatal encephalopathy.
Several possible preventive strategies also emerged from AWAKEN data. Early administration of caffeine citrate in preterm infants was associated with reduced incidence and severity of AKI, a finding that has led to additional investigation of the potential protective effects of this therapeutic intervention.
AWAKEN 2.0 and Ongoing Research in Neonatal AKI
Since its original publication, the AWAKEN study’s dataset has provided the foundation for more than 20 subsequent studies probing various aspects of how and when AKI develops and its long-term consequences.
Building on this progress, the AWAKEN 2.0 study launched in 2025, expanding the network of participating sites to more than 100 centers in 30 countries. The next phase of AWAKEN aims to refine the diagnostic thresholds for AKI in neonates, evaluate long-term kidney outcomes, and improve early recognition and prevention strategies.
“The expansion of AWAKEN 2.0 reflects a growing commitment to understanding neonatal kidney disease through coordinated, multicenter science,” Dr. Beck says. “These efforts are helping shape standards for AKI surveillance and follow-up in high-risk infants.”
Reference
Read more about the AWAKEN study and its findings using the reference link below.
