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

Running, not enrolling

Conditions studied: Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation

In brief

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 facts

Study ID

NCT05388708

Run by

University of Michigan

People needed

550

Starts

2021-02-04

Expected to finish

2027-09-30

Last updated by the study team

2026-07-14

Who can join

Age: 0 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• 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
• Children's of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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