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Newborn kidney health under the microscope: AWAKEN 2.0 launches

NCT ID NCT06823115

Knowledge-focused Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This study looks at how common kidney injury is in newborns in intensive care and what factors increase the risk. Researchers will review medical records of about 4,000 babies from hospitals around the world. The goal is to better understand short- and long-term kidney health, but no new treatments or medications are being tested.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 4,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The investigators will conduct a multi-center retrospective cohort study. All infants admitted to the NICU between January 1, 2019 and March 31, 2019 will be screened for the 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 2018 at our centers who meet inclusion and exclusion criteria, it is estimated that it can enroll approximately 4000 infants during this time.

Ages

0 minutes to 2 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. All infants born or admitted to a participating level 3 or 4 NICU between 1/1/19- 3/31/19 will be screened. 2. Infants who received intravenous fluids for \> 48 hours will be eligible. Exclusion Criteria: 1. Age \> 14 days at admission 2. Congenital heart disease requiring transfer for escalation of CHD care and/or surgery within the first 7 days 3. Lethal chromosomal anomalies 4. Neonatal mortality \<48 hours

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Conditions

The condition(s) this trial relates to.

acute kidney injury chronic kidney disease chronic renal failure syndrome Edema hypertensive disorder Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute kidney injury Chronic kidney disease (CKD) Epidemiology Fluid overload Hypertension Prematurity complications Risk factors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    87 sites in 19 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aghia Sofia Children's Hospital

    Athens, Greece

  • Akron Children's Hospital

    Akron, Ohio, 44308, United States

  • Alberta Children's Hospital/University of Calgary

    Calgary, Canada

  • Amalia Children's Hospital Radboudumc

    Nijmegen, Netherlands

  • Ankara Bilkent City Hospital, Children Hospital

    Ankara, Turkey (Türkiye)

  • Aristotle University

    Thessaloniki, Greece

  • Baptist Health South Florida/South Miami Hospital

    South Miami, Florida, 33176, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Bukovinian State Medical University

    Chernivtsi, Ukraine

  • Centro Materno Infantil de Norte Albino Aroso, Unidade Local de Saude de Santo Antonio

    Porto, Portugal

  • Centro de Alta Especialidad del Estado de Veracruz

    Veracruz, Mexico

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital at Montefiore

    The Bronx, New York, 10467, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108, United States

  • Children's National Hospital

    Washington D.C., District of Columbia, 20010, United States

  • Children's Nebraska

    Omaha, Nebraska, 68114, United States

  • Christian Medical College

    Vellore, India

  • Christus Children's Hospital

    San Antonio, Texas, 78207, United States

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229, United States

  • Clínica Universitaria Bolivariana

    Medellín, Colombia

  • Cohen Children's Hospital

    Queens, New York, 11040, United States

  • Cukurova University

    Adana, Turkey (Türkiye)

  • Dr. Mehta's Hospitals

    Chennai, India

  • Emory Healthcare / Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322, United States

  • Fundacion Valle del Lili Cali

    Cali, Colombia

  • Golisano Children's Hospital at University of Vermont Health

    Burlington, Vermont, 05401, United States

  • Hippokration General Hospital of Thessaloniki

    Thessaloniki, Greece

  • Hospital Occidente de Kennedy

    Bogotá, Colombia

  • Hospital Santa Maria, Unidade Local de Saude de Santa Maria

    Lisbon, Portugal

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Brazil

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

  • Institute for the Care of Mother and Child

    Prague, Czechia

  • Joana de Gusmao Children's Hospital

    Florianópolis, Brazil

  • Johns Hopkins University/Hospital

    Baltimore, Maryland, 21287, United States

  • Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Maimonides Medical Center

    Brooklyn, New York, 11219, United States

  • Marmara University Pendik Research and Training Hospital

    Istanbul, Turkey (Türkiye)

  • McGill University

    Montreal, Canada

  • McMaster Children's Hospital

    Hamilton, Canada

  • Medical College of Wisconsin / Children's Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Miami Children's / Nichlaus Children's Hospital

    Miami, Florida, 33155, United States

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

    Nashville, Tennessee, 37232, United States

  • Mount Sinai Hospital

    Toronto, Canada

  • Nationwide Children's

    Columbus, Ohio, 43205, United States

  • OHSU

    Portland, Oregon, 97239, United States

  • Perth Children's Hospital

    Perth, Australia

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113, United States

  • Puerta del Mar University Hospital

    Cadiz, Spain

  • Rady Children's Hospital/UCSD

    San Diego, California, 92123, United States

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202, United States

  • SIU

    Springfield, Illinois, 62702, United States

  • Seattle Children's Hospital / University of Washington

    Seattle, Washington, 98105, United States

  • St Francis Nsambya

    Kampala, Uganda

  • St. John's Medical College Hospital

    Bengaluru, India

  • Stanford Children's

    Palo Alto, California, 94304, United States

  • Stollery Children's Hospital

    Edmonton, Canada

  • Stony Brook Medicine

    Stony Brook, New York, 11794, United States

  • Sunnybrook Health Sciences Center

    Toronto, Canada

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • Texas Tech

    Lubbock, Texas, 79415, United States

  • The Hospital for Sick Children

    Toronto, Ontario, Canada

  • The Royal Children's Hospital Melbourne

    Melbourne, Victoria, Australia

  • ULS Sao Joan

    Porto, Portugal

  • UNC

    Chapel Hill, North Carolina, 27514, United States

  • UT Southwestern

    Dallas, Texas, 75235, United States

  • University Hospital of Heraklion

    Heraklion, Greece

  • University Medical Centre Ljubljana

    Ljubljana, Slovenia

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72202, United States

  • University of Cologne

    Cologne, Germany

  • University of Ibadan

    Ibadan, Nigeria

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

  • University of Louisville

    Louisville, Kentucky, 40202, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Rochester / Golisano Children's Hospital

    Rochester, New York, 14642, United States

  • University of Szeged Children's Hospital

    Szeged, Hungary

  • University of Virginia

    Charlottesville, Virginia, 22930, United States

  • University of Wisconsin

    Madison, Wisconsin, 53792, United States

  • Wake Forest

    Winston-Salem, North Carolina, 27157, United States

  • Washington University

    St Louis, Missouri, 63110, United States

  • Westchester Medical Center/Maria Fareri Children's Hospital

    Westchester, New York, 10595, United States

  • Yale University

    New Haven, Connecticut, 06511, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.