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Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0

NCT06823115 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 4000

Last updated 2026-04-17

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Neonatal Kidney Collaborative

    collaborator UNKNOWN

  • Indiana University

    lead OTHER

Eligibility

Min Age
0 Minutes
Max Age
2 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Colombia
  • Czechia
  • Germany
  • Greece
  • Hungary
  • India
  • Mexico
  • Netherlands
  • Nigeria
  • Portugal
  • Slovenia
  • Spain
  • Turkey (Türkiye)
  • Uganda
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06823115 on ClinicalTrials.gov