Status:
RECRUITING
ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Acute Respiratory Distress Syndrome
Extracorporeal Membrane Oxygenation
Eligibility:
All Genders
14-20 years
Brief 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 syndro...
Detailed Description
Decades after extracorporeal membrane oxygenation (ECMO) was first used to support children with severe pediatric acute respiratory distress syndrome (PARDS), pediatric intensivists lack both prospect...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 4 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT05388708
Start Date
February 4 2021
End Date
September 30 2027
Last Update
December 24 2025
Active Locations (99)
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1
Children's of Alabama
Birmingham, Alabama, United States, 35233
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
3
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
4
Loma Linda University Children's Hospital
Loma Linda, California, United States, 92354