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Detecting Brain Injury in Children on ECMO with Hyperfine MRI

This study is looking at how often and what types of acute brain injury (ABI) happen in children who need ECMO (extracorporeal membrane oxygenation) support. ECMO is a machine that helps people with very sick hearts or lungs. Doctors know that brain injuries can happen during ECMO, but it's hard to see them early with current imaging. This study uses a special portable MRI machine called Hyperfine, which can be used right at the bedside. You or your child would have Hyperfine MRI scans at different times while on ECMO. The study aims to see if this portable MRI can help doctors find brain injuries sooner. This study is for children aged 0 days to 17 years who are at high risk for or are currently receiving ECMO. The study is currently unclear about its recruitment status and plans to enroll 30 participants.

Study design
This interventional study plans to enroll 30 participants. It uses a portable, low-field MRI device called Hyperfine to image participants.
What's involved
You or your child would undergo a Hyperfine MRI exam at various times during ECMO treatment, with the first scan within 36 hours of starting ECMO.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured during the duration of ECMO treatment, which averages less than 2 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06469801

ECMO ABI Detection With Hyperfine

Recruiting
NAAges 0–17InterventionalDiagnostic
Children's Mercy Hospital Kansas City
~40 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:Hyperfine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support.
Measured over Duration of ECMO treatment period, an average of <2 weeks

Conditions

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

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NCT06469801

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's Mercy

    Kansas City, Missouristudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jessica Wallisch, MD · PRINCIPAL_INVESTIGATOR · Children's Mercy Kansas City

Who to contact

Maura Sien, MSML, CCRC
[email protected]
8163028311 · ext. 78311
Email the study team

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Eligibility criteria

Inclusion

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
Undergoing cardiac surgery
Congenital heart disease
Congenital diaphragmatic hernia
Refractory hypoxemic and/or hypercarbic respiratory failure
Vasoactive-refractory shock

Exclusion

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

What this trial measures

  • Characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support.Duration of ECMO treatment period, an average of <2 weeks

    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).