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Massive study aims to crack the code on Kids' medications

NCT ID NCT04278404

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Updated 3 times

Summary

This study is collecting blood and other samples from 5,000 children and young adults (under 21) who are already taking certain medications as part of their regular care. The goal is to understand how these drugs move through and affect children's bodies, so doctors can prescribe the safest and most effective doses. The study covers many conditions, from COVID-19 to heart failure, and includes drugs like antibiotics, pain relievers, and heart medications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Various drugs (e.g., amiodarone, furosemide, oxycodone, metformin) given as part of standard care
What this could lead to
If successful, this could help doctors determine the safest and most effective doses of common drugs for children, improving pediatric care.
What could go wrong
This is an observational study collecting data from routine care, not testing new treatments. Results may take years to influence practice and may not apply to all children.

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 5,000 people

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

Started

Mar 2020

Expected to finish

Dec 2026

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

Children under 21 years of age.

Ages

0 to 20 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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. Participant is \< 21 years of age 2. Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA: 3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment Exclusion Criteria: 1. Participant has a known pregnancy Below exclusion criteria apply only to: Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria) 2. Has had intermittent dialysis within previous 24 hours 3. Has had a kidney transplant within previous 30 days 4. Has had a liver transplant within previous 1 year 5. Has had a stem cell transplant within previous 1 year 6. Has had therapeutic hypothermia within previous 24 hours 7. Has had plasmapheresis within the previous 24 hours 8. Has a Ventricular Assist Device 9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

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Conditions

The condition(s) this trial relates to.

adrenocortical insufficiency Arrhythmias, Cardiac attention deficit hyperactivity disorder, inattentive type attention deficit-hyperactivity disorder blood coagulation disease bronchopulmonary dysplasia cardiac rhythm disease cellulitis childhood onset asthma Coronavinae infectious disease COVID-19 COVID-19–associated multisystem inflammatory syndrome in children Down syndrome Edema heart failure hemophilia hemophilia A Hemorrhage hyperaldosteronism hyperphosphatemia hypertensive disorder insomnia Kawasaki disease Menorrhagia Pain pediatric multisystem inflammatory disease, COVID-19 related pneumonia potassium deficiency disease pulmonary arterial hypertension skin infection urinary tract infection vascular hemostatic disease

As listed by the trial registrant

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

Adrenal insufficiency Arrythmia Asthma in children Attention deficit hyperactivity disorder Bronchopulmonary dysplasia Coagulation disorder Coronavirus infection (COVID-19) Down syndrome Edema Fibrinolysis; hemorrhage Heart failure Hemophilia Hyperphosphatemia Hypertension Hypokalemia Insomnia Kawasaki disease Menorrhagia Multisystem inflammatory syndrome in children (mis-C) Pain Pneumonia Primary hyperaldosteronism Pulmonary arterial hypertension Skin infection Urinary tract infections in children

How to take part

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

  1. The places running it

    5 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Alfred I. DuPont Hospital for Children

    COMPLETED

    Wilmington, Delaware, 19803, United States

  • Ann and Robert H. Lurie Childrens Hospital of Chicago

    COMPLETED

    Chicago, Illinois, 60611, United States

  • Ann and Robert H. Lurie Childrens Hospital of Chicago

    COMPLETED

    Chicago, Illinois, 60614, United States

  • Arkansas Children's Hospital Research Institute

    COMPLETED

    Little Rock, Arkansas, 72202, United States

  • Avera McKennan Hospital & University Medical Center

    COMPLETED

    Sioux Falls, South Dakota, 57108, United States

  • Baylor College of Medicine

    COMPLETED

    Houston, Texas, 77030, United States

  • Board of Regents of the University of Oklahoma

    COMPLETED

    Oklahoma City, Oklahoma, 73104, United States

  • Boston Children's Hospital

    COMPLETED

    Boston, Massachusetts, 02115, United States

  • CHU Sainte-Justine

    RECRUITING

    Montreal, Quebec, H3T 1C5, Canada

  • Children's Mercy Hospital

    COMPLETED

    Kansas City, Missouri, 64108, United States

  • Cincinnati Childrens Hospital Medical Center

    COMPLETED

    Cincinnati, Ohio, 45229, United States

  • Cincinnati Childrens Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Colorado University Denver

    COMPLETED

    Aurora, Colorado, 80045, United States

  • Dartmouth-Hitchcock Medical Center

    COMPLETED

    Lebanon, New Hampshire, 03756, United States

  • Dell Children's Medical Center of Central Texas

    RECRUITING

    Austin, Texas, 78723, United States

  • Duke University Health System

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Kapiolani Womens and Childrens Medical Center

    COMPLETED

    Honolulu, Hawaii, 96826, United States

  • Lucile Packard Children's Hospital

    RECRUITING

    Palo Alto, California, 94304, United States

  • Massachusetts General Hospital

    COMPLETED

    Lexington, Massachusetts, 02421, United States

  • Medical College of Wisconsin

    COMPLETED

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina Children's Hospital

    COMPLETED

    Charleston, South Carolina, 29425, United States

  • Mississippi Center for Advanced Medicine

    COMPLETED

    Madison, Mississippi, 39110, United States

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

    COMPLETED

    Nashville, Tennessee, 37232, United States

  • Ochsner Baptist Clinical Trials Unit

    COMPLETED

    New Orleans, Louisiana, 70115, United States

  • Oregon Health and Science University

    COMPLETED

    Portland, Oregon, 97239, United States

  • Pennsylvania State University--Hershey Children's Hospital

    COMPLETED

    Hershey, Pennsylvania, 17033, United States

  • Phoenix Children's Hospital

    COMPLETED

    Phoenix, Arizona, 85016, United States

  • Rhode Island Hospital

    COMPLETED

    Providence, Rhode Island, 02903, United States

  • Riley Hospital for Children at Indiana University

    COMPLETED

    Indianapolis, Indiana, 46202, United States

  • Seattle Children's Hospital

    COMPLETED

    Seattle, Washington, 98105, United States

  • The Children's Hospital Colorado

    COMPLETED

    Aurora, Colorado, 80045, United States

  • The Hospital for Sick Children

    COMPLETED

    Toronto, Ontario, Canada

  • The Womens Hospital of Texas

    COMPLETED

    Houston, Texas, 77054, United States

  • Tulane University Health Science Center

    COMPLETED

    New Orleans, Louisiana, 70112, United States

  • University Wisconsin Madison

    COMPLETED

    Madison, Wisconsin, 53705, United States

  • University of California, Los Angeles Medical Center

    COMPLETED

    Los Angeles, California, 90095, United States

  • University of Florida Jacksonville Shands Medical Center

    COMPLETED

    Jacksonville, Florida, 32209, United States

  • University of Iowa Stead Family Children's Hospital

    COMPLETED

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center-JG Kidney Institute

    COMPLETED

    Kansas City, Kansas, 66160, United States

  • University of Louisville Norton Childrens Hospital

    COMPLETED

    Louisville, Kentucky, 40202, United States

  • University of Maryland Medical Center

    COMPLETED

    Baltimore, Maryland, 21201, United States

  • University of Minnesota

    COMPLETED

    Minneapolis, Minnesota, 55455, United States

  • University of Mississippi Medical Center

    COMPLETED

    Jackson, Mississippi, 39216, United States

  • University of Nebraska Medical Center

    COMPLETED

    Omaha, Nebraska, 68114, United States

  • University of New Mexico Health Science Center

    COMPLETED

    Albuquerque, New Mexico, 87131, United States

  • University of North Carolina at Chapel Hill

    COMPLETED

    Chapel Hill, North Carolina, 27599, United States

  • University of South Carolina

    COMPLETED

    Columbia, South Carolina, 29208, United States

  • University of Texas--Memorial Hermann Texas Medical Center

    COMPLETED

    Houston, Texas, 77030, United States

  • University of Texas-Southwestern Medical Center Dallas

    COMPLETED

    Dallas, Texas, 75390, United States

  • University of Utah

    COMPLETED

    Salt Lake City, Utah, 84113, United States

  • University of Wisconsin

    COMPLETED

    Madison, Wisconsin, 53705, United States

  • West Virginia University Hospital

    COMPLETED

    Morgantown, West Virginia, 26506, United States

More trials for these conditions

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