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RECRUITING Not applicable ClinicalTrials.gov

ECMO ABI Detection With Hyperfine

Sponsor: Children's Mercy Hospital Kansas City • ClinicalTrials.gov ID: NCT06469801

Registry updated: 2026-09-24
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Description

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.

Interventions

  • Hyperfine (Device)
    Enrolled subjects will undergo a Hyperfine MRI exam, which is a portable, low-field MRI, at various timepoints during their clinical course on ECMO. Patients will undergo imaging within 36 hours of ECMO initiation/cannulation. Patients that remain on ECMO will have repeat imaging at 72-120 hours of ECMO therapy and again weekly for the duration of their ECMO course. Patients may also undergo a portable MRI within 24 hours of clinical head imaging, if applicable.

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 * Any patient who has a contraindication to having an MRI * Patients with a passive or active implant will: * First be reviewed on MRISafety.com to determine MR conditionality * If device is listed as Conditional or Unsafe for a 1.5T or a 3T, device will then be reviewed by MRI Safety Officer or MRI Physician Section chief to determine true conditionality for the portable MRI

Conditions

Acute Brain Injury Extracorporeal Membrane Oxygenation Complication Hypoxia-Ischemia, Brain Stroke, Acute

Locations

  • Children's Mercy — Kansas City, Missouri, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record