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Recruiting
NCT06469801
ECMO ABI Detection With Hyperfine
Conditions: Acute Brain Injury, Extracorporeal Membrane Oxygenation Complication, Hypoxia-Ischemia, Brain, Stroke, Acute
Sex: All
Ages: 0 Days – 17 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Children's Mercy Hospital Kansas City
Location: Children's Mercy Kansas City Missouri
Summary
The primary objective is to characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support. The secondary objective is to describe the time course and rates of ABI using ultralow-field bedside MRI relative to both duration of ECMO support and clinical imaging obtained in routine care of pediatric ECMO patients.
Eligibility Criteria
Inclusion Criteria
* Participants that will be or are admitted to the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or the Neonatal Intensive Care Unit
* Ages 0-17 years
* Participants that are at high risk for undergoing ECMO or are currently undergoing venovenous or venoarterial ECMO
• High risk participants include, but are not limited to:
* Undergoing cardiac surgery
* Congenital heart disease
* Congenital diaphragmatic hernia
* Refractory hypoxemic and/or hypercarbic respiratory failure
* Vasoactive-refractory shock
Exclusion Criteria
* Pregnancy
* Active implants such as:
* Pacemaker
* Implanted defibrillator
* Implanted insulin pump
* Deep brain stimulator
* Vagus nerve stimulator
* Cochlear implant
* Programmable shunt
* MRI incompatible surgical hardware (e.g., staples, screws, etc.)
* Metal-containing tattoos or permanent make-up on head or neck
* Suspected metal in eye, e.g.,
* Former or current welders, metal workers, or individuals with a metal injury
* Metal shrapnel
* Passive implants are considered MRI-conditional
Source: ClinicalTrials.gov (NCT06469801). StuddyBuddy aggregates publicly available trial information.