Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates

NCT02443389 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2186

Last updated 2022-12-15

No results posted yet for this study

Summary

Introduction:

Based on single-center data, approximately 1 of every 3 newborns admitted to tertiary level neonatal intensive care units (NICU) develops acute kidney injury (AKI), and those with AKI have significantly worse outcomes. To stimulate discussion among researchers, the NIH NIDDK sponsored a workshop on neonatal AKI in April 2013. At that workshop, the group recognized the need to improve collaborations between neonatologists and nephrologists within and across centers. The investigators have created a multi-institutional, multi-disciplinary group, Neonatal Kidney Collaborative (NKC), in order to address the following critical needs identified at the workshop: AWAKEN is the inaugural study of this new collaboration.

1. Development of a standardized evidence-based definition of neonatal AKI
2. Evaluation of risk factors that predispose neonatal to AKI
3. Investigation into how fluid provision/ balance impacts biochemical and clinical outcomes

Conditions

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER
  • George Washington University

    collaborator OTHER
  • McGill University

    collaborator OTHER
  • Albert Einstein College of Medicine

    collaborator OTHER
  • University of Rochester

    collaborator OTHER
  • University of British Columbia

    collaborator OTHER
  • University of Iowa

    collaborator OTHER
  • University of Michigan

    collaborator OTHER
  • University of New Mexico

    collaborator OTHER
  • University of Virginia

    collaborator OTHER
  • University of Washington

    collaborator OTHER
  • University of Miami

    collaborator OTHER
  • Case Western Reserve University

    collaborator OTHER
  • University of Kentucky

    collaborator OTHER
  • Maimonides Medical Center

    collaborator OTHER
  • Stony Brook University

    collaborator OTHER
  • The Canberra Hospital

    collaborator OTHER
  • Children's Hospital Colorado

    collaborator OTHER
  • St. Louis Children's Hospital

    collaborator OTHER
  • Baylor College of Medicine

    collaborator OTHER
  • Medanta, The Medicity, India

    collaborator OTHER
  • Ohio State University

    collaborator OTHER
  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • David Askenazi, MD · University of Alabama at Birmingham

Eligibility

Min Age
1 Minute
Max Age
2 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-01-31
Completion
2016-03-31

Countries

  • United States

Study Locations

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Entities

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 NCT02443389 on ClinicalTrials.gov