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

Status: Recruiting
Location: See all (99) locations...
Intervention Type: Device, Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14 days
Maximum Age: 20
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
Children's of Alabama
RECRUITING
Birmingham
Arkansas
Arkansas Children's Hospital
RECRUITING
Little Rock
Arizona
Phoenix Children's Hospital
RECRUITING
Phoenix
California
Loma Linda University Children's Hospital
RECRUITING
Loma Linda
UCLA Mattel Children's Hospital
RECRUITING
Los Angeles
Valley Children's Hospital
RECRUITING
Madera
UCSF Benioff Children's Hospital Oakland
RECRUITING
Oakland
Children's Hospital of Orange County
RECRUITING
Orange
Lucile Packard Children's Hospital Stanford
RECRUITING
Palo Alto
UCSF Benioff Children's Hospital - San Francisco
RECRUITING
San Francisco
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Connecticut
Connecticut Children's Medical Center
RECRUITING
Hartford
Yale New Haven Children's Hospital
RECRUITING
New Haven
Delaware
Nemours Children's Hospital, Delaware
RECRUITING
Wilmington
Florida
UF Health Shands Children's Hospital
RECRUITING
Gainesville
Nicklaus Children's Hospital
WITHDRAWN
Miami
Nemours Children's Hospital, Florida
RECRUITING
Orlando
Orlando Health Arnold Palmer Hospital for Children
RECRUITING
Orlando
Georgia
Children's Healthcare of Atlanta
RECRUITING
Atlanta
Hawaii
Kapi'olani Medical Center for Women & Children
RECRUITING
Honolulu
Iowa
University of Iowa Health Care Stead Family Children's Hospital
RECRUITING
Iowa City
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Comer Children's Hospital
RECRUITING
Chicago
OSF Healthcare Children's Hospital of Illinois
RECRUITING
Peoria
Indiana
Riley Hospital for Children
RECRUITING
Indianapolis
Kentucky
Norton Children's Hospital
RECRUITING
Louisville
Louisiana
Ochsner LSU Health Shreveport
RECRUITING
Shreveport
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Maryland
Johns Hopkins Children's Center
RECRUITING
Baltimore
University of Maryland Children's Hospital
WITHDRAWN
Baltimore
Michigan
University of Michigan - Mott Children's Hospital
RECRUITING
Ann Arbor
Children's Hospital of Michigan
RECRUITING
Detroit
Helen DeVos Children's Hospital
RECRUITING
Grand Rapids
Minnesota
Children's Minnesota Hospital
RECRUITING
Minneapolis
M Health Fairview Masonic Children's Hospital
WITHDRAWN
Minneapolis
Mayo Eugenio Litta Children's Hospital
RECRUITING
Rochester
Missouri
Children's Mercy
RECRUITING
Kansas City
Cardinal Glennon Children's Hospital
RECRUITING
St Louis
St. Louis Children's Hospital
RECRUITING
St Louis
North Carolina
N.C. Children's Hospital
RECRUITING
Chapel Hill
Duke Children's Hospital & Health Center
RECRUITING
Durham
Atrium Health Wake Forest Baptist | Brenner Children's Hospital
RECRUITING
Winston-salem
Nebraska
Children's Nebraska
RECRUITING
Omaha
New Mexico
UNM Children's Hospital
RECRUITING
Albuquerque
New York
John R. Oishei Children's Hospital
RECRUITING
Buffalo
Hassenfeld Children's Hospital at NYU Langone
RECRUITING
New York
NewYork-Presbyterian Komansky Children's Hospital
RECRUITING
New York
NewYork-Presbyterian Morgan Stanley Children's Hospital
RECRUITING
New York
Cohen Children's Medical Center
RECRUITING
Queens
Ohio
Akron Children's Hospital
RECRUITING
Akron
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Cleveland Clinic Children's Hospital
RECRUITING
Cleveland
Nationwide Children's Hospital
RECRUITING
Columbus
Oklahoma
Oklahoma Children's Hospital OU Health
RECRUITING
Oklahoma City
Oregon
OHSU Doernbecher Children's Hospital
RECRUITING
Portland
Pennsylvania
Penn State Health Children's Hospital
RECRUITING
Hershey
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
UPMC Children's Hospital of Pittsburgh
RECRUITING
Pittsburgh
Rhode Island
Hasbro Children's
RECRUITING
Providence
South Carolina
MUSC Shawn Jenkins Children's Hospital
RECRUITING
Charleston
South Dakota
Sanford Children's Hospital
RECRUITING
Sious Falls
Tennessee
Le Bonheur Children's Hospital
RECRUITING
Memphis
Monroe Carell Jr. Children's Hospital at Vanderbilt
RECRUITING
Nashville
Texas
Dell Children's Medical Center
RECRUITING
Austin
Children's Medical Center Dallas
RECRUITING
Dallas
Medical City Children's Hospital
RECRUITING
Dallas
Children's Memorial Hermann Hospital
RECRUITING
Houston
Texas Children's Hospital
RECRUITING
Houston
University Health Women's & Children's Hospital
RECRUITING
San Antonio
Utah
Primary Children's Hospital
RECRUITING
Salt Lake City
Virginia
UVA Children's Hospital
RECRUITING
Charlottesville
Inova L.J. Murphy Children's Hospital
RECRUITING
Falls Church
Children's Hospital of Richmond at VCU
WITHDRAWN
Richmond
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Wisconsin
UW Health American Family Children's Hospital
RECRUITING
Madison
Children's Wisconsin
RECRUITING
Milwaukee
Other Locations
Australia
The Royal Children's Hospital Melbourne
RECRUITING
Melbourne
Perth Children's Hospital
RECRUITING
Perth
Queensland Children's Hospital
RECRUITING
South Brisbane
The Children's Hospital at Westmead
RECRUITING
Westmead
Canada
Stollery Children's Hospital
RECRUITING
Edmonton
The Hospital for Sick Children
RECRUITING
Toronto
Chile
Pontificia Universidad
RECRUITING
Santiago
Colombia
Fundacion Cardiovascular De Colombia
RECRUITING
Floridablanca
Italy
Istituto Giannina Gaslini
RECRUITING
Genoa
New Zealand
Starship Children's Hospital
RECRUITING
Grafton
Portugal
Hospital de Santa Maria
RECRUITING
Lisbon
Spain
Children's Hospital and Vall d' Hebron Women's Hospital
RECRUITING
Barcelona
Sant Joan de Deu Barcelona Hospital
RECRUITING
Barcelona
Hospital Gregorio Maranon
RECRUITING
Madrid
Sweden
ECMO Centrum Karolinska
RECRUITING
Stockholm
United Kingdom
Royal Hospital for Children
RECRUITING
Glasgow
Leicester Children's Hospital
RECRUITING
Leicester
Alder Hey Children's Hospital
RECRUITING
Liverpool
Evelina London Children's Hospital
RECRUITING
London
Great Ormond Street Hospital for Children
RECRUITING
London
Royal Brompton Hospital
RECRUITING
London
Freeman Hospital
RECRUITING
Newcastle Upon Tyne
Southampton Children's Hospital
RECRUITING
Southampton
Contact Information
Primary
Kelli McDonough, MS
kellimcd@umich.edu
734-232-1998
Time Frame
Start Date: 2021-02-04
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 550
Treatments
Usual care ECMO Cohort
The cohort will be comprised of 550 patients, aged 14 days to 20 years, who go on extracorporeal membrane oxygenation (ECMO) support due to pediatric acute respiratory distress syndrome (PARDS) at physician discretion. Patients with qualifying PARDS must have one oxygenation index (OI) ≥ 16 or two OIs 12 ≥ to \< 16 (at least 4 hours apart) or two oxygenation saturation indexes (OSIs) ≥ 10 (at least 4 hours apart) or one OI 12 ≥ to \< 16 and one OSI \> 10 (at least 4 hours apart) Subjects must be on mechanical ventilation for less than 240 hours (10 days) prior to cannulation. These measures must be after endotracheal intubation and before ECMO start. Chest radiograph prior to ECMO must show bilateral lung disease.~Subjects cannulated on ECMO for no more than 96 hours prior to gaining consent.
PROSpect protocolized therapies cohort
The cohort will be comprised of 1000 patients, aged 14 days to 20 years, who are endotracheally intubated for PARDS. Patients with qualifying PARDS must have one oxygenation index (OI) ≥ 16 or two OIs 12 ≥ to \< 16 (at least 4 hours apart) or two oxygenation saturation indexes (OSIs) ≥ 10 (at least 4 hours apart) or one OI 12 ≥ to \< 16 and one OSI \> 10 (at least 4 hours apart). These measures must be after endotracheal intubation. Chest radiograph must show bilateral lung disease. Patient must be enrolled in a clinical trial Prone and Oscillation Pediatric Clinical Trial (PROSpect) NCT01515787 which is distinct from ASCEND.~PROSpect is a response adaptive randomized clinical trial, testing the impact of supine/prone positioning and conventional mechanical ventilation/high-frequency oscillatory ventilation on short and long-term clinical outcomes in children with severe PARDS. PROSpect manages severe PARDS subjects using a rigorous protocol that reserves ECMO for protocol failure.
Sponsors
Leads: University of Michigan
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov

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