NCT05388708 · University of Michigan
ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)
(ASCEND)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Birmingham, Alabama
- Phoenix, Arizona
- Little Rock, Arkansas
- Loma Linda, California
- Los Angeles, California
- Madera, California
- Oakland, California
- Orange, California
- Palo Alto, California
- San Francisco, California
- Aurora, Colorado
- Hartford, Connecticut
And 55 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 24, 2025 · Source of record for eligibility and locations