ECMO ABI Detection With Hyperfine

NCT06469801 | Recruiting FDA Device

• 1 other identifier: STUDY00003208
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Pediatric

Outcome Measures

Primary Outcomes (2)

• Characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support.

  Perform bedside MRI in pediatric ECMO patients treated in pediatric, cardiac, and neonatal intensive care units (ICUs) within 36 hours of cannulation. Determine rates of ABI (hypoxic, ischemic, cerebrovascular, and hemorrhagic injury along with assessment of cerebral edema and midline shift) in the pre- and peri-cannulation time periods. Correlate these imaging findings to rates of clinical neurological events (seizures, pupillary changes, focal neurological examination).

  Duration of ECMO treatment period, an average of <2 weeks

• 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.

  Obtain bedside MRI in pediatric ECMO patients treated in pediatric, cardiac or neonatal ICUs at 72-120 hours post-cannulation and weekly until decannulation. Quantify and compare rates of ABI between bedside MRI and CT or US as read by blinded neuroradiologist.

  Duration of ECMO treatment period, an average of <2 weeks

Secondary Outcomes (1)

• Assess the association of clinical neurologic events to presence and type of imaging findings.

  From ICU admission to final neuroimaging during active study participation

Study Arms (1)

Portable MRI Arm

EXPERIMENTAL

All subjects enrolled will be assigned to Arm 1

Device: Hyperfine

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.

Portable MRI Arm

Eligibility Criteria

• Age: 0 Days - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy

Kansas City, Missouri, 64108, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Hypoxia-Ischemia, Brain; Stroke

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Ischemia; Cerebrovascular Disorders; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jessica Wallisch, MD

  Children's Mercy Kansas City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maura Sien, MSML, CCRC

CONTACT

8163028311; mesien@cmh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Pediatric neuroradiologists performing portable MRI assessments are blinded to clinical neuroimaging results.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Intensivist

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 24, 2024
• Study Start: July 23, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)