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

December 13, 2022 updated by: David Askenazi, University of Alabama at Birmingham

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

Study Overview

Status

Completed

Conditions

Detailed Description

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, and estimate that it can enroll approximately 3000 infants during this time.

A. Specific Aim 1: Determine if the proposed neonatal AKI definition adapted to neonates is able to predict mortality, length of stay, and discharge serum creatinine (SCr).

  1. Our primary hypothesis is that higher stages of AKI are associated with mortality, even after controlling for severity of illness, interventions and demographics.

  2. Populations

    1. Inclusion Criteria - All infants born or admitted to a level 2 or 3 NICU will be screened. Infants who received intravenous fluids for > 48 hours will be eligible.
    2. Exclusion -- Infants admitted to the NICU at 2 weeks of age or older; Infants who undergo cardiovascular surgery repair of a congenital heart lesion within 1 week of life; Infants diagnosed with a lethal anomaly upon admission; Infants who die within 48 hours after birth
  3. Primary Exposure - Neonatal AKI definitions (table 3)

  4. Primary Outcome - Survival

    1. In premature infants - defined as survival to 36 weeks post gestational age or hospital discharge (whichever comes first)
    2. In term infants - defined as hospital survival to 28 days.

  5. Secondary outcomes

    1. Hospital length of stay
    2. Last serum creatinine obtained
  6. Potential confounders - gestational age, birth weight, 5 minute APGAR score, multiple gestation, significant renal anomalies, SNAP-II score
  7. Exploratory outcomes - recognize that the proposed definition may not be the best definition to predict clinical outcomes. Also recognize that there may be a need to have different definitions for premature infants. The investigators plan to explore how other definitions reported in the literature can predict these outcomes (for example using the 90th % for normative values). In addition, this will have the largest comprehensive database to explore new definitions which could incorporate urine output, fluid balance and other factors.

B. Specific Aim 2: Define the risk factors associated with neonatal AKI.

  1. Our hypothesis is that maternal and infant risk factors will predict AKI.
  2. Population - same as in Specific Aim 1
  3. Design - randomize cohort to a prediction and a validation groups. Develop a risk factor prediction model with the first group, and test the ability of the model to predict AKI with the second group.

  4. Exposures (see full list in appendix 1 - Data collection sheets)

    1. Maternal Demographic Factors
    2. Neonatal Demographic Factors
    3. Interventions / Medications
    4. Co-Morbidities
  5. Primary Outcome - KDIGO AKI definition modified for neonates (Table 3).

C. Specific Aim 3: Determine how fluid balance during the first few weeks of life relates to biochemical data and clinical outcomes.

  1. Our hypotheses are that fluid provision affects chemistry panels (serum creatinine, blood urea nitrogen, serum sodium) and that fluid balance is associated with clinical outcomes.
  2. Population - same as in Specific Aim 1

  3. Design

    1. Evaluation of fluid balance - will use birth weight as the reference weight and calculate changes in weight over time as a percentage of birth weight.
    2. Will describe the association between fluid balance and changes in serum creatinine (SCr), blood urea nitrogen (BUN) and serum sodium.
    3. Will then evaluate how fluid balance (and the associated biochemical changes) affects clinical outcomes.

  4. Primary Clinical Outcome - Survival

    1. In premature infants - defined as survival to 36 weeks post gestational age or hospital discharge (whichever comes first)
    2. In term infants - defined as hospital survival to 28 days.

  5. Secondary outcomes

    1. Hospital length of stay
    2. Ventilator free days in the first 28 days of life.
    3. Bronchopulmonary dysplasia
    4. Intraventricular hemorrhage
    5. Last serum creatinine obtained
    6. Use of blood pressure support medications
    7. Use of diuretics
    8. Patent ductus arteriosus

Data will be captured at each institution and entered into web-based forms in real time.

The investigators plan to have 5 different integrated forms:

  1. Screening form
  2. Baseline form for included infants
  3. Daily Assessment form (first 7 days after birth)
  4. Weekly Assessment form (weeks 2 - 18)
  5. Discharge form

Study Type

Observational

Enrollment (Actual)

2186

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University Of Alabama

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
NICU admit though 18 weeks hospitalization or hospital discharge whichever comes first.
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.
NICU admit though 18 weeks hospitalization or hospital discharge whichever comes first.
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.
NICU admit though 18 weeks hospitalization or hospital discharge whichever comes first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Baylor College of Medicine
University of British Columbia
McGill University
Albert Einstein College of Medicine
University of Miami
University of Michigan
University of Iowa
Children's Hospital Colorado
Stony Brook University
University of Washington
Ohio State University
George Washington University
Children's Hospital Medical Center, Cincinnati
Maimonides Medical Center
University of Virginia
University of Rochester
University of Kentucky
Case Western Reserve University
St. Louis Children's Hospital
University of New Mexico
Medanta, The Medicity, India
The Canberra Hospital

Investigators

  • Principal Investigator: David Askenazi, MD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

May 12, 2015

First Posted (Estimate)

May 13, 2015

Study Record Updates

Last Update Posted (Estimate)

December 15, 2022

Last Update Submitted That Met QC Criteria

December 13, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X140917002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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