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ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)
Sponsor: University of Michigan
Summary
ASCEND researchers are partnering with families of children who receive extracorporeal membrane oxygenation (ECMO) after a sudden failure of breathing named pediatric acute respiratory distress syndrome (PARDS). ECMO is a life support technology that uses an artificial lung outside of the body to do the lung's work. ASCEND has two objectives. The first objective is to learn more about children's abilities and quality of life among ECMO-supported children in the year after they leave the pediatric intensive care unit. The second objective is to compare short and long-term patient outcomes in two groups of children: one group managed with a mechanical ventilation protocol that reserves the use of extracorporeal membrane oxygenation (ECMO) until protocol failure to another group supported on ECMO per usual care.
Key Details
Gender
All
Age Range
14 Days - 20 Years
Study Type
OBSERVATIONAL
Enrollment
550
Start Date
2021-02-04
Completion Date
2027-09-30
Last Updated
2025-12-24
Healthy Volunteers
No
Interventions
ECMO support
ECMO prescribed by treating physicians for respiratory support in the setting of PARDS.
PROSpect protocolized therapies
PROSpect is testing the impact of supine/prone positioning and conventional mechanical ventilation (CMV)/high-frequency oscillatory ventilation (HFOV) on clinical outcomes in 1,000 children with severe PARDS. PROSpect manages severe PARDS subjects using a protocol that reserves ECMO for protocol failure. The CMV group targets an exhaled tidal volume of 5-7mL/kg of ideal body weight and a peak inspiratory pressure \<28 cm of H2O. The positive end expiratory pressure (PEEP) and FiO2 are titrated by a PEEP-FiO2 titration grid. The HFOV group titrates the mean airway pressure to target a FiO2 \< 0.5 and a goal hemoglobin oxygen saturation of 88-92%. The frequency is titrated between 8-12 Hz and amplitude from 60-90 to achieve a goal pH of 7.15-7.30. Ventilation protocols are implemented until 28 days or extubation. Children randomized to the prone positioning will remain prone for at least 16 consecutive hours per day. Children randomized to supine positioning group remain supine.
Locations (99)
Children's of Alabama
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Loma Linda University Children's Hospital
Loma Linda, California, United States
UCLA Mattel Children's Hospital
Los Angeles, California, United States
Valley Children's Hospital
Madera, California, United States
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States
Children's Hospital of Orange County
Orange, California, United States
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States
UCSF Benioff Children's Hospital - San Francisco
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Yale New Haven Children's Hospital
New Haven, Connecticut, United States
Nemours Children's Hospital, Delaware
Wilmington, Delaware, United States
UF Health Shands Children's Hospital
Gainesville, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Orlando Health Arnold Palmer Hospital for Children
Orlando, Florida, United States
Nemours Children's Hospital, Florida
Orlando, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Kapi'olani Medical Center for Women & Children
Honolulu, Hawaii, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Comer Children's Hospital
Chicago, Illinois, United States
OSF Healthcare Children's Hospital of Illinois
Peoria, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
University of Iowa Health Care Stead Family Children's Hospital
Iowa City, Iowa, United States
Norton Children's Hospital
Louisville, Kentucky, United States
Ochsner LSU Health Shreveport
Shreveport, Louisiana, United States
University of Maryland Children's Hospital
Baltimore, Maryland, United States
Johns Hopkins Children's Center
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan - Mott Children's Hospital
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
Children's Minnesota Hospital
Minneapolis, Minnesota, United States
M Health Fairview Masonic Children's Hospital
Minneapolis, Minnesota, United States
Mayo Eugenio Litta Children's Hospital
Rochester, Minnesota, United States
Children's Mercy
Kansas City, Missouri, United States
Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Children's Nebraska
Omaha, Nebraska, United States
UNM Children's Hospital
Albuquerque, New Mexico, United States
John R. Oishei Children's Hospital
Buffalo, New York, United States
Hassenfeld Children's Hospital at NYU Langone
New York, New York, United States
NewYork-Presbyterian Morgan Stanley Children's Hospital
New York, New York, United States
NewYork-Presbyterian Komansky Children's Hospital
New York, New York, United States
Cohen Children's Medical Center
Queens, New York, United States
N.C. Children's Hospital
Chapel Hill, North Carolina, United States
Duke Children's Hospital & Health Center
Durham, North Carolina, United States
Atrium Health Wake Forest Baptist | Brenner Children's Hospital
Winston-Salem, North Carolina, United States
Akron Children's Hospital
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic Children's Hospital
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oklahoma Children's Hospital OU Health
Oklahoma City, Oklahoma, United States
OHSU Doernbecher Children's Hospital
Portland, Oregon, United States
Penn State Health Children's Hospital
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Hasbro Children's
Providence, Rhode Island, United States
MUSC Shawn Jenkins Children's Hospital
Charleston, South Carolina, United States
Sanford Children's Hospital
Sious Falls, South Dakota, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Dell Children's Medical Center
Austin, Texas, United States
Medical City Children's Hospital
Dallas, Texas, United States
Children's Medical Center Dallas
Dallas, Texas, United States
Children's Memorial Hermann Hospital
Houston, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
University Health Women's & Children's Hospital
San Antonio, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
UVA Children's Hospital
Charlottesville, Virginia, United States
Inova L.J. Murphy Children's Hospital
Falls Church, Virginia, United States
Children's Hospital of Richmond at VCU
Richmond, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
UW Health American Family Children's Hospital
Madison, Wisconsin, United States
Children's Wisconsin
Milwaukee, Wisconsin, United States
The Royal Children's Hospital Melbourne
Melbourne, Australia
Perth Children's Hospital
Perth, Australia
Queensland Children's Hospital
South Brisbane, Australia
The Children's Hospital at Westmead
Westmead, Australia
Stollery Children's Hospital
Edmonton, Alberta, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Pontificia Universidad
Santiago, Chile
Fundacion Cardiovascular De Colombia
Floridablanca, Colombia
Istituto Giannina Gaslini
Genoa, Italy
Starship Children's Hospital
Grafton, Aukland, New Zealand
Hospital de Santa Maria
Lisbon, Portugal
Children's Hospital and Vall d' Hebron Women's Hospital
Barcelona, Spain
Sant Joan de Deu Barcelona Hospital
Barcelona, Spain
Hospital Gregorio Maranon
Madrid, Spain
ECMO Centrum Karolinska
Stockholm, Sweden
Royal Hospital for Children
Glasgow, United Kingdom
Leicester Children's Hospital
Leicester, United Kingdom
Alder Hey Children's Hospital
Liverpool, United Kingdom
Evelina London Children's Hospital
London, United Kingdom
Royal Brompton Hospital
London, United Kingdom
Great Ormond Street Hospital for Children
London, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Southampton Children's Hospital
Southampton, United Kingdom