Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates (AWAKEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02443389
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : May 18, 2020
Sponsor:
Collaborators:
Children's Hospital Medical Center, Cincinnati
George Washington University
McGill University
Albert Einstein College of Medicine
University of Rochester
University of British Columbia
University of Iowa
University of Michigan
University of New Mexico
University of Virginia
University of Washington
University of Miami
Case Western Reserve University
University of Kentucky
Maimonides Medical Center
Stony Brook University
The Canberra Hospital
Children's Hospital Colorado
St. Louis Children's Hospital
Baylor College of Medicine
Medanta, The Medicity, India
Ohio State University
Information provided by (Responsible Party):
David Askenazi, University of Alabama at Birmingham

Brief 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

Condition or disease
Acute Kidney Injury

Show Show detailed description

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 2186 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 120 Days
Official Title: Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates
Study Start Date : March 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : March 2016

Group/Cohort
Neonates admitted to NICU
Retrospective cohort of neonates admitted to NICU with stated inclusion and exclusion criteria



Primary Outcome Measures :
  1. Determine if the KDIGO AKI definition adapted to neonates can predict mortality, length of stay, and discharge serum creatinine (SCr). [ Time Frame: NICU admit though 18 weeks hospitalization or hospital discharge whichever comes first. ]
  2. Define the major risk factors associated with neonatal AKI. We will randomly split the cohort into two groups. We will develop a risk factor prediction model with the first group, and test the ability of the model to predict AKI with the second group. [ Time Frame: NICU admit though 18 weeks hospitalization or hospital discharge whichever comes first. ]
  3. Determine how fluid balance during the first few weeks of life relates to biochemical data and clinical outcomes. [ Time Frame: NICU admit though 18 weeks hospitalization or hospital discharge whichever comes first. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The investigators will conduct a multi-center retrospective cohort study. The investigators will enroll eligible infants who meet inclusion and exclusion criteria at each center for 3 consecutive months. Based on average admissions for 2013 at our centers who meet inclusion and exclusion criteria, it is estimated that it can enroll approximately 3000 infants during this time. All infants admitted to the NICU between January 1, 2014 and march 31, 2014 will be screened for the study.
Criteria

Inclusion Criteria:

  1. All infants born or admitted to a level 2 or 3 NICU will be screened.
  2. Infants who received intravenous fluids for > 48 hours will be eligible.

Exclusion Criteria:

  1. Infants admitted to the NICU at 2 weeks of age or older
  2. Infants who undergo cardiovascular surgery repair of a congenital heart lesion within 1 week of life
  3. Infants diagnosed with a lethal anomaly upon admission
  4. Infants who die within 48 hours after birth

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443389


Locations
Layout table for location information
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Children's Hospital Medical Center, Cincinnati
George Washington University
McGill University
Albert Einstein College of Medicine
University of Rochester
University of British Columbia
University of Iowa
University of Michigan
University of New Mexico
University of Virginia
University of Washington
University of Miami
Case Western Reserve University
University of Kentucky
Maimonides Medical Center
Stony Brook University
The Canberra Hospital
Children's Hospital Colorado
St. Louis Children's Hospital
Baylor College of Medicine
Medanta, The Medicity, India
Ohio State University
Investigators
Layout table for investigator information
Principal Investigator: David Askenazi, MD University of Alabama at Birmingham
Additional Information:

Publications:

Layout table for additonal information
Responsible Party: David Askenazi, MD, MsPH, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02443389    
Other Study ID Numbers: X140917002
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Askenazi, University of Alabama at Birmingham:
nephrotoxic
Fluid overload
Acute renal failure
Prematurity
Risk factors
Epidemiology
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases