What is this study trying to find out about pediatric acute respiratory distress syndrome (PARDS)?

This study is evaluating long-term outcomes and quality of life in children with PARDS who receive ECMO support compared to those managed with a ventilation protocol that delays ECMO. Researchers aim to understand how different ECMO initiation strategies affect survival, functioning, and well-being. The University of Michigan is leading this research to improve care for children with severe lung failure.

Who may be eligible for this pediatric PARDS clinical trial?

Children from 14 days to 20 years old with moderate to severe PARDS and bilateral lung disease may be eligible. They must have been intubated and on mechanical ventilation for less than 10 days before ECMO. Children previously enrolled in the PROSpect trial or with certain heart or lung conditions are not eligible. Please review eligibility criteria for more details.

Is there any cost to participate in this pediatric PARDS clinical trial?

Study-related care, including ECMO support or ventilation treatments and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants can expect care and monitoring as part of the trial without additional charges for study procedures.

Actively Recruiting

Age: 14Days - 20Years

All Genders

ID05388708

ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)

Led by University of Michigan · Updated on 2025-12-24

550

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying children with pediatric acute respiratory distress syndrome (PARDS) who receive extracorporeal membrane oxygenation (ECMO), a life support technology that uses an artificial lung outside the body. This study aims to learn about the children's abilities and quality of life during the year after they leave the pediatric intensive care unit. It also compares outcomes between children managed with a mechanical ventilation protocol that delays ECMO use until failure and those receiving ECMO as usual care. The study involves two groups: one cohort of 550 children aged 14 days to 20 years supported by ECMO due to PARDS, and another cohort of 1,000 children in a randomized clinical trial called PROSpect, which tests different ventilation strategies and reserves ECMO for protocol failure. ECMO support is prescribed by physicians, and ventilation protocols include supine or prone positioning and conventional or high-frequency oscillatory ventilation. The study follows patients from intubation through ECMO or ventilation management. Participants are assessed at baseline (normal health before hospitalization), at pediatric intensive care unit discharge, and at 1, 3, 6, and 12 months afterward. Researchers collect data on functional status, quality of life, respiratory support needs, mortality, and other health outcomes. Surveys, chest radiographs, and oxygenation measures are used to monitor progress. The study combines observational data and randomized trial data to evaluate short- and long-term effects of ECMO initiation strategies over a follow-up period of one year.

CONDITIONS

Brief Title

ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)

Who Can Participate

Age: 14Days - 20Years

All Genders

Eligibility Criteria

You may qualify if you...

Time between intubation and ECMO cannulation is less than 240 hours (10 days)
ECMO support type is respiratory (VV or VA cannulation)
Chest radiograph shows 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 oxygenation index (OI) ≥ 16 or two OIs between 12 and 16 at least 4 hours apart
Two oxygenation saturation indexes (OSIs) ≥ 10 at least 4 hours apart
One OI between 12 and 16 and one OSI ≥ 10 at least 4 hours apart
Age between 14 days and 20 years

You will not qualify if you...

Previously enrolled in PROSpect trial
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 or open abdomen
Family or medical team decided to not provide full support
Enrolled in another interventional clinical trial not approved for co-enrollment
Known pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 1 year after pediatric intensive care unit discharge

Participants who undergo routine care for severe pediatric acute respiratory distress syndrome (PARDS) are observed. This includes children receiving usual care ECMO support or PROSpect protocolized therapies involving different ventilation and positioning strategies.

Visits at discharge and at 1, 3, 6, and 12 months after pediatric intensive care unit discharge

Trial Site Locations

Total: 99 locations

Children's of Alabama

Birmingham, Alabama, United States, 35233

Actively Recruiting

Phoenix Children's Hospital

Phoenix, Arizona, United States, 85016

Actively Recruiting

Arkansas Children's Hospital

Little Rock, Arkansas, United States, 72202

Actively Recruiting

Loma Linda University Children's Hospital

Loma Linda, California, United States, 92354

Actively Recruiting

UCLA Mattel Children's Hospital

Los Angeles, California, United States, 90095

Actively Recruiting

Valley Children's Hospital

Madera, California, United States, 93636

Actively Recruiting

UCSF Benioff Children's Hospital Oakland

Oakland, California, United States, 94609

Actively Recruiting

Children's Hospital of Orange County

Orange, California, United States, 92868

Actively Recruiting

Lucile Packard Children's Hospital Stanford

Palo Alto, California, United States, 94304

Actively Recruiting

UCSF Benioff Children's Hospital - San Francisco

San Francisco, California, United States, 94158

Actively Recruiting

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

Connecticut Children's Medical Center

Hartford, Connecticut, United States, 06106

Actively Recruiting

Yale New Haven Children's Hospital

New Haven, Connecticut, United States, 06511

Actively Recruiting

Nemours Children's Hospital, Delaware

Wilmington, Delaware, United States, 19803

Actively Recruiting

UF Health Shands Children's Hospital

Gainesville, Florida, United States, 32608

Actively Recruiting

Nicklaus Children's Hospital

Miami, Florida, United States, 33155

Withdrawn

Orlando Health Arnold Palmer Hospital for Children

Orlando, Florida, United States, 32806

Actively Recruiting

Nemours Children's Hospital, Florida

Orlando, Florida, United States, 32827

Actively Recruiting

Children's Healthcare of Atlanta

Atlanta, Georgia, United States, 30342

Actively Recruiting

Kapi'olani Medical Center for Women & Children

Honolulu, Hawaii, United States, 96826

Actively Recruiting

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

Chicago, Illinois, United States, 60611

Actively Recruiting

Comer Children's Hospital

Chicago, Illinois, United States, 60637

Actively Recruiting

OSF Healthcare Children's Hospital of Illinois

Peoria, Illinois, United States, 61637

Actively Recruiting

Riley Hospital for Children

Indianapolis, Indiana, United States, 46202

Actively Recruiting

University of Iowa Health Care Stead Family Children's Hospital

Iowa City, Iowa, United States, 52242

Actively Recruiting

Norton Children's Hospital

Louisville, Kentucky, United States, 40202

Actively Recruiting

Ochsner LSU Health Shreveport

Shreveport, Louisiana, United States, 71103

Actively Recruiting

University of Maryland Children's Hospital

Baltimore, Maryland, United States, 21201

Withdrawn

Johns Hopkins Children's Center

Baltimore, Maryland, United States, 21287

Actively Recruiting

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

University of Michigan - Mott Children's Hospital

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

Children's Hospital of Michigan

Detroit, Michigan, United States, 48201

Actively Recruiting

Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States, 49503

Actively Recruiting

Children's Minnesota Hospital

Minneapolis, Minnesota, United States, 55404

Actively Recruiting

M Health Fairview Masonic Children's Hospital

Minneapolis, Minnesota, United States, 55454

Withdrawn

Mayo Eugenio Litta Children's Hospital

Rochester, Minnesota, United States, 55902

Actively Recruiting

Children's Mercy

Kansas City, Missouri, United States, 64108

Actively Recruiting

Cardinal Glennon Children's Hospital

St Louis, Missouri, United States, 63104

Actively Recruiting

St. Louis Children's Hospital

St Louis, Missouri, United States, 63110

Actively Recruiting

Children's Nebraska

Omaha, Nebraska, United States, 68114

Actively Recruiting

UNM Children's Hospital

Albuquerque, New Mexico, United States, 87106

Actively Recruiting

John R. Oishei Children's Hospital

Buffalo, New York, United States, 14203

Actively Recruiting

Hassenfeld Children's Hospital at NYU Langone

New York, New York, United States, 10016

Actively Recruiting

NewYork-Presbyterian Morgan Stanley Children's Hospital

New York, New York, United States, 10032

Actively Recruiting

NewYork-Presbyterian Komansky Children's Hospital

New York, New York, United States, 10065

Actively Recruiting

Cohen Children's Medical Center

Queens, New York, United States, 11040

Actively Recruiting

N.C. Children's Hospital

Chapel Hill, North Carolina, United States, 27514

Actively Recruiting

Duke Children's Hospital & Health Center

Durham, North Carolina, United States, 27705

Actively Recruiting

Atrium Health Wake Forest Baptist | Brenner Children's Hospital

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

Akron Children's Hospital

Akron, Ohio, United States, 44308

Actively Recruiting

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

Cleveland Clinic Children's Hospital

Cleveland, Ohio, United States, 44106

Actively Recruiting

Nationwide Children's Hospital

Columbus, Ohio, United States, 43215

Actively Recruiting

Oklahoma Children's Hospital OU Health

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

OHSU Doernbecher Children's Hospital

Portland, Oregon, United States, 97239

Actively Recruiting

Penn State Health Children's Hospital

Hershey, Pennsylvania, United States, 17033

Actively Recruiting

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15224

Actively Recruiting

Hasbro Children's

Providence, Rhode Island, United States, 02903

Actively Recruiting

MUSC Shawn Jenkins Children's Hospital

Charleston, South Carolina, United States, 29425

Actively Recruiting

Sanford Children's Hospital

Sious Falls, South Dakota, United States, 57105

Actively Recruiting

Le Bonheur Children's Hospital

Memphis, Tennessee, United States, 38103

Actively Recruiting

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States, 37232

Actively Recruiting

Dell Children's Medical Center

Austin, Texas, United States, 78723

Actively Recruiting

Medical City Children's Hospital

Dallas, Texas, United States, 75230

Actively Recruiting

Children's Medical Center Dallas

Dallas, Texas, United States, 75235

Actively Recruiting

Children's Memorial Hermann Hospital

Houston, Texas, United States, 77030

Actively Recruiting

Texas Children's Hospital

Houston, Texas, United States, 77030

Actively Recruiting

University Health Women's & Children's Hospital

San Antonio, Texas, United States, 78229

Actively Recruiting

Primary Children's Hospital

Salt Lake City, Utah, United States, 84113

Actively Recruiting

UVA Children's Hospital

Charlottesville, Virginia, United States, 22903

Actively Recruiting

Inova L.J. Murphy Children's Hospital

Falls Church, Virginia, United States, 22042

Actively Recruiting

Children's Hospital of Richmond at VCU

Richmond, Virginia, United States, 23219

Withdrawn

Seattle Children's Hospital

Seattle, Washington, United States, 98105

Actively Recruiting

UW Health American Family Children's Hospital

Madison, Wisconsin, United States, 53792

Actively Recruiting

Children's Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

The Royal Children's Hospital Melbourne

Melbourne, Australia, VIC 3052

Actively Recruiting

Perth Children's Hospital

Perth, Australia, WA 6009

Actively Recruiting

Queensland Children's Hospital

South Brisbane, Australia, QLD 4101

Actively Recruiting

The Children's Hospital at Westmead

Westmead, Australia, NSW 2145,

Actively Recruiting

Stollery Children's Hospital

Edmonton, Alberta, Canada, T6G 2B7

Actively Recruiting

The Hospital for Sick Children

Toronto, Ontario, Canada, M5G 1E8

Actively Recruiting

Pontificia Universidad

Santiago, Chile, 8331150

Actively Recruiting

Fundacion Cardiovascular De Colombia

Floridablanca, Colombia, 681004

Actively Recruiting

Istituto Giannina Gaslini

Genoa, Italy, 16147

Actively Recruiting

Starship Children's Hospital

Grafton, Aukland, New Zealand, 1023

Actively Recruiting

Hospital de Santa Maria

Lisbon, Portugal, 1649-028

Actively Recruiting

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

Barcelona, Spain, 08035

Actively Recruiting

Sant Joan de Deu Barcelona Hospital

Barcelona, Spain, 08950

Actively Recruiting

Hospital Gregorio Maranon

Madrid, Spain, 28007

Actively Recruiting

ECMO Centrum Karolinska

Stockholm, Sweden, 17176

Actively Recruiting

Royal Hospital for Children

Glasgow, United Kingdom, G51 4FT

Actively Recruiting

Leicester Children's Hospital

Leicester, United Kingdom, LE3 9QP

Actively Recruiting

Alder Hey Children's Hospital

Liverpool, United Kingdom, L12 2AP

Actively Recruiting

Evelina London Children's Hospital

London, United Kingdom, SE1 7EH

Actively Recruiting

Royal Brompton Hospital

London, United Kingdom, SW3 6NP

Actively Recruiting

Great Ormond Street Hospital for Children

London, United Kingdom, WC1N 3JH

Actively Recruiting

Freeman Hospital

Newcastle upon Tyne, United Kingdom, NE77DN

Actively Recruiting

Southampton Children's Hospital

Southampton, United Kingdom, SO16 6YD

Actively Recruiting

Loading map...

Research Team

Kelli McDonough, MS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

Similar Trials

Continuous Positive Airway Pressure on Venovenous extracorpo...

Acute Respiratory Distress Syndrome

Actively Recruiting

11 locations

A Phase I-II Open-label Dose-escalation Trial of Human Umbil...

Acute Respiratory Distress Syndrome

Actively Recruiting

1 location

A Comparative Study of Glucocorticoids Efficacy in Acute Res...

Acute Respiratory Distress Syndrome

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Assessing the outcome of pediatric intensive care.

D H Fiser

https://pubmed.ncbi.nlm.nih.gov/1625096

Functional Status Scale: new pediatric outcome measure.

Murray M Pollack, Richard Holubkov, Penny Glass...

https://pubmed.ncbi.nlm.nih.gov/19564265

PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations.

J W Varni, M Seid, P S Kurtin

https://pubmed.ncbi.nlm.nih.gov/11468499

The PedsQL: measurement model for the pediatric quality of life inventory.

J W Varni, M Seid, C A Rode

https://pubmed.ncbi.nlm.nih.gov/10024117

Simultaneous Prediction of New Morbidity, Mortality, and Survival Without New Morbidity From Pediatric Intensive Care: A New Paradigm for Outcomes Assessment.

Murray M Pollack, Richard Holubkov, Tomohiko Funai...

https://pubmed.ncbi.nlm.nih.gov/25985385

New Morbidity and Discharge Disposition of Pediatric Acute Respiratory Distress Syndrome Survivors.

Garrett Keim, R Scott Watson, Neal J Thomas...

https://pubmed.ncbi.nlm.nih.gov/30024428

Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome.

Alain Combes, David Hajage, Gilles Capellier...

https://pubmed.ncbi.nlm.nih.gov/29791822

ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)

On this page

Sponsors

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

AI-Screening

AI-Powered Screening

Your Study Journey

Trial Site Locations

Research Team

How is the study designed?

Similar Trials

Continuous Positive Airway Pressure on Venovenous extracorpo...

A Phase I-II Open-label Dose-escalation Trial of Human Umbil...

A Comparative Study of Glucocorticoids Efficacy in Acute Res...

Frequently Asked Questions

What is this study trying to find out about pediatric acute respiratory distress syndrome (PARDS)?

Who may be eligible for this pediatric PARDS clinical trial?

Is there any cost to participate in this pediatric PARDS clinical trial?

What will I be asked to do in this pediatric PARDS study?

How is the child's lung function and quality of life measured during the study?

What happens after this pediatric PARDS clinical trial ends?

Can I leave this pediatric PARDS clinical trial if I change my mind?

Not the Right Trial for You?

Published Research Related To This Trial

Assessing the outcome of pediatric intensive care.

Functional Status Scale: new pediatric outcome measure.

PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations.

The PedsQL: measurement model for the pediatric quality of life inventory.

Simultaneous Prediction of New Morbidity, Mortality, and Survival Without New Morbidity From Pediatric Intensive Care: A New Paradigm for Outcomes Assessment.

New Morbidity and Discharge Disposition of Pediatric Acute Respiratory Distress Syndrome Survivors.

Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome.

On this page

Sponsors