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New study tracks kids on life support to see how timing affects their brains

NCT ID NCT05388708

Knowledge-focused Sponsor: University of Michigan 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 15, 2026 · Updated 2 times

Summary

This study follows 550 children who need ECMO (a machine that does the work of the lungs) after sudden, severe breathing failure. Researchers will track their abilities and quality of life for a year after leaving the ICU. They will also compare two groups: one that received ECMO only after other treatments failed, and another that got ECMO as part of usual care.

What this could mean

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

What this could lead to
If successful, this study could help doctors choose the best timing for ECMO to improve children's long-term brain development and quality of life.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test a new therapy. Results may take years and might 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 550 people

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

Started

Feb 2021

Expected to finish

Sep 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 study population comes from pediatric patients hospitalized for respiratory distress requiring intubation and ECMO. Namely, children are eligible if they have moderate to severe PARDS, meet inclusion criteria and do not have the exclusion criteria listed below under exclusion criteria. Children in ELSO's usual care ECMO cohort also cannot be enrolled in PROSpect, and they must have respiratory ECMO initiated at an ELSO site within 10 days of intubation.

Ages

14 days to 20 years

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: * Time between intubation and ECMO cannulation is less than 240 hours (10 days) * ECMO support type is respiratory (VV or VA cannulation) * Chest radiograph with bilateral lung disease * Moderate or severe pediatric ARDS as measured by oxygenation index or oxygen saturation index after intubation and prior to ECMO cannulation: One OI ≥ 16 or Two OIs ≥ 12 and ≤ 16 at least four hours apart or Two OSIs ≥ 10 at least four hours apart or One OI ≥ 12 and ≤ 16 and One OSI ≥ 10 at least four hours apart Exclusion Criteria: * Previously enrolled in PROSpect * Perinatal related lung disease * Congenital diaphragmatic hernia or congenital/acquired diaphragm paralysis * Respiratory failure caused by cardiac failure or fluid overload * Cyanotic congenital heart disease * Cardiomyopathy * Primary pulmonary hypertension (PAH) * Unilateral lung disease * Intubated for status asthmaticus * Obstructive airway disease * Bronchiolitis obliterans * Post hematopoietic stem cell transplant * Post lung transplant * Home ventilator dependent * Neuromuscular respiratory failure * Head trauma: (managed with hyperventilation) * Intracranial bleeding * Unstable spine, femur or pelvic fractures * Acute abdominal process/open abdomen * Family/medical team have decided to not provide full support * Enrolled in interventional clinical trial: not approved for co-enrollment; does not include cancer protocols. * Known pregnancy

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome pediatric acute respiratory distress syndrome

As listed by the trial registrant

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

Acute respiratory distress syndrome Extracorporeal membrane oxygenation

Contacts and locations

Locations

  • Akron Children's Hospital

    Akron, Ohio, 44308, United States

  • Alder Hey Children's Hospital

    Liverpool, L12 2AP, United Kingdom

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202, United States

  • Atrium Health Wake Forest Baptist | Brenner Children's Hospital

    Winston-Salem, North Carolina, 27157, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Cardinal Glennon Children's Hospital

    St Louis, Missouri, 63104, United States

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30342, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital and Vall d' Hebron Women's Hospital

    Barcelona, 08035, Spain

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201, United States

  • Children's Hospital of Orange County

    Orange, California, 92868, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Medical Center Dallas

    Dallas, Texas, 75235, United States

  • Children's Memorial Hermann Hospital

    Houston, Texas, 77030, United States

  • Children's Mercy

    Kansas City, Missouri, 64108, United States

  • Children's Minnesota Hospital

    Minneapolis, Minnesota, 55404, United States

  • Children's Nebraska

    Omaha, Nebraska, 68114, United States

  • Children's Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Children's of Alabama

    Birmingham, Alabama, 35233, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Cleveland Clinic Children's Hospital

    Cleveland, Ohio, 44106, United States

  • Cohen Children's Medical Center

    Queens, New York, 11040, United States

  • Comer Children's Hospital

    Chicago, Illinois, 60637, United States

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106, United States

  • Dell Children's Medical Center

    Austin, Texas, 78723, United States

  • Duke Children's Hospital & Health Center

    Durham, North Carolina, 27705, United States

  • ECMO Centrum Karolinska

    Stockholm, 17176, Sweden

  • Evelina London Children's Hospital

    London, SE1 7EH, United Kingdom

  • Freeman Hospital

    Newcastle upon Tyne, NE77DN, United Kingdom

  • Fundacion Cardiovascular De Colombia

    Floridablanca, 681004, Colombia

  • Great Ormond Street Hospital for Children

    London, WC1N 3JH, United Kingdom

  • Hasbro Children's

    Providence, Rhode Island, 02903, United States

  • Hassenfeld Children's Hospital at NYU Langone

    New York, New York, 10016, United States

  • Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503, United States

  • Hospital Gregorio Maranon

    Madrid, 28007, Spain

  • Hospital de Santa Maria

    Lisbon, 1649-028, Portugal

  • Inova L.J. Murphy Children's Hospital

    Falls Church, Virginia, 22042, United States

  • Istituto Giannina Gaslini

    Genoa, 16147, Italy

  • John R. Oishei Children's Hospital

    Buffalo, New York, 14203, United States

  • Johns Hopkins Children's Center

    Baltimore, Maryland, 21287, United States

  • Kapi'olani Medical Center for Women & Children

    Honolulu, Hawaii, 96826, United States

  • Le Bonheur Children's Hospital

    Memphis, Tennessee, 38103, United States

  • Leicester Children's Hospital

    Leicester, LE3 9QP, United Kingdom

  • Loma Linda University Children's Hospital

    Loma Linda, California, 92354, United States

  • Lucile Packard Children's Hospital Stanford

    Palo Alto, California, 94304, United States

  • MUSC Shawn Jenkins Children's Hospital

    Charleston, South Carolina, 29425, United States

  • Mayo Eugenio Litta Children's Hospital

    Rochester, Minnesota, 55902, United States

  • Medical City Children's Hospital

    Dallas, Texas, 75230, United States

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

    Nashville, Tennessee, 37232, United States

  • N.C. Children's Hospital

    Chapel Hill, North Carolina, 27514, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43215, United States

  • Nemours Children's Hospital, Delaware

    Wilmington, Delaware, 19803, United States

  • Nemours Children's Hospital, Florida

    Orlando, Florida, 32827, United States

  • NewYork-Presbyterian Komansky Children's Hospital

    New York, New York, 10065, United States

  • NewYork-Presbyterian Morgan Stanley Children's Hospital

    New York, New York, 10032, United States

  • Norton Children's Hospital

    Louisville, Kentucky, 40202, United States

  • OHSU Doernbecher Children's Hospital

    Portland, Oregon, 97239, United States

  • OSF Healthcare Children's Hospital of Illinois

    Peoria, Illinois, 61637, United States

  • Ochsner LSU Health Shreveport

    Shreveport, Louisiana, 71103, United States

  • Oklahoma Children's Hospital OU Health

    Oklahoma City, Oklahoma, 73104, United States

  • Orlando Health Arnold Palmer Hospital for Children

    Orlando, Florida, 32806, United States

  • Penn State Health Children's Hospital

    Hershey, Pennsylvania, 17033, United States

  • Perth Children's Hospital

    Perth, WA 6009, Australia

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016, United States

  • Pontificia Universidad

    Santiago, 8331150, Chile

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113, United States

  • Queensland Children's Hospital

    South Brisbane, QLD 4101, Australia

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202, United States

  • Royal Brompton Hospital

    London, SW3 6NP, United Kingdom

  • Royal Hospital for Children

    Glasgow, G51 4FT, United Kingdom

  • Sanford Children's Hospital

    Sious Falls, South Dakota, 57105, United States

  • Sant Joan de Deu Barcelona Hospital

    Barcelona, 08950, Spain

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • Southampton Children's Hospital

    Southampton, SO16 6YD, United Kingdom

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110, United States

  • Starship Children's Hospital

    Grafton, Aukland, 1023, New Zealand

  • Stollery Children's Hospital

    Edmonton, Alberta, T6G 2B7, Canada

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • The Children's Hospital at Westmead

    Westmead, NSW 2145,, Australia

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1E8, Canada

  • The Royal Children's Hospital Melbourne

    Melbourne, VIC 3052, Australia

  • UCLA Mattel Children's Hospital

    Los Angeles, California, 90095, United States

  • UCSF Benioff Children's Hospital - San Francisco

    San Francisco, California, 94158, United States

  • UCSF Benioff Children's Hospital Oakland

    Oakland, California, 94609, United States

  • UF Health Shands Children's Hospital

    Gainesville, Florida, 32608, United States

  • UNM Children's Hospital

    Albuquerque, New Mexico, 87106, United States

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • UVA Children's Hospital

    Charlottesville, Virginia, 22903, United States

  • UW Health American Family Children's Hospital

    Madison, Wisconsin, 53792, United States

  • University Health Women's & Children's Hospital

    San Antonio, Texas, 78229, United States

  • University of Iowa Health Care Stead Family Children's Hospital

    Iowa City, Iowa, 52242, United States

  • University of Michigan - Mott Children's Hospital

    Ann Arbor, Michigan, 48109, United States

  • Valley Children's Hospital

    Madera, California, 93636, United States

  • Yale New Haven Children's Hospital

    New Haven, Connecticut, 06511, United States

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