Actively Recruiting

Phase Not Applicable
Age: 0Days - 17Years
All Genders
ID06469801

Low-Field Bedside MRI for Detection of Acute Brain Injury in Pediatric ECMO Support

Led by Children's Mercy Hospital Kansas City · Updated on 2025-08-15

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying acute brain injury (ABI) in children who require extracorporeal membrane oxygenation (ECMO) support, a treatment used for severe heart and lung failure. The study aims to understand how common and what types of brain injuries occur after starting ECMO in pediatric patients. It also seeks to track the timing and rates of these brain injuries using a new bedside MRI technology compared to standard clinical imaging methods. The study uses a portable, ultralow-field MRI device called Hyperfine, which can safely be used at the bedside even with ECMO equipment that usually cannot be near traditional MRI machines. Children will have MRI scans within 36 hours of starting ECMO, then again between 72 and 120 hours, and weekly for as long as they remain on ECMO. Additional MRIs may be done within 24 hours of any clinical head imaging if applicable. During the study, children will be monitored closely in intensive care units with repeated bedside MRIs and clinical imaging to detect brain injury. Researchers will assess how often and when brain injuries develop during the ECMO treatment, which typically lasts less than two weeks. This monitoring will help characterize brain injury types and timing in this vulnerable population, with the total participation lasting for the duration of ECMO support.

CONDITIONS

Brief Title

ECMO ABI Detection With Hyperfine

Who Can Participate

Age: 0Days - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants admitted to the Pediatric, Cardiac, or Neonatal Intensive Care Unit
  • Ages 0 to 17 years
  • At high risk for or currently undergoing venovenous or venoarterial ECMO
  • High risk includes patients undergoing cardiac surgery, with congenital heart disease, congenital diaphragmatic hernia, refractory respiratory failure, or vasoactive-refractory shock
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Presence of active implants such as pacemaker, implanted defibrillator, insulin pump, deep brain stimulator, vagus nerve stimulator, cochlear implant, or programmable shunt
  • MRI incompatible surgical hardware like staples or screws
  • Metal-containing tattoos or permanent makeup on head or neck
  • Suspected metal in the eye (e.g., former welders, metal workers, or metal injuries)
  • Presence of metal shrapnel
  • Passive implants that are MRI-conditional are allowed

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

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

Participants undergo portable low-field MRI brain imaging at the bedside during their ECMO treatment to detect acute brain injury.

Imaging within 36 hours of ECMO start, repeat imaging at 72-120 hours, and then weekly for the duration of ECMO; additional imaging within 24 hours of clinical head imaging if applicable

Trial Site Locations

Total: 1 location

1

Children's Mercy

Kansas City, Missouri, United States, 64108

Actively Recruiting

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Research Team

M

Maura Sien, MSML, CCRC

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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