Low-Field MRI for Pediatric ECMO Patients

Overseen By Maura Sien, RT(R)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Mercy Hospital Kansas City

Disqualifiers: Pregnancy, Active implants, Metal shrapnel, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and usability of a new, portable MRI machine designed for children and infants on ECMO (a machine that helps the heart and lungs rest). The goal is to determine if this low-field MRI can effectively capture images while patients remain in intensive care. If a child is in the Pediatric, Cardiac, or Neonatal Intensive Care Unit at Children's Mercy Kansas City and is on ECMO, this trial might be suitable.

As an unphased trial, this study offers a unique opportunity to contribute to innovative medical technology that could enhance care for children in intensive care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this low-field MRI is safe for pediatric ECMO patients?

Research has shown that low-field bedside MRI is safe for children on ECMO, a machine that supports heart and lung function. In past studies, children on ECMO underwent MRI scans without significant changes to their treatment. The ECMO machine maintained its flow and oxygen supply effectively.

Another study found that adults on ECMO, requiring additional heart support, could also safely undergo this type of MRI in the intensive care unit. This suggests that low-field MRI is generally well-tolerated, even in serious health situations.

These findings indicate that low-field bedside MRI does not cause major issues and is safe for these patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard imaging techniques for pediatric ECMO patients, which typically involve moving patients to a traditional MRI suite, low-field bedside MRI offers a unique advantage by being portable. This allows for real-time monitoring of critically ill children without the risks associated with transferring them to another location. Researchers are excited about this method because it enables safer, more convenient imaging that could lead to quicker decision-making and improved patient outcomes. Additionally, the low-field strength reduces the need for sedation and decreases the risk of adverse effects linked to high magnetic fields, making it a promising option for this vulnerable patient group.

What evidence suggests that this low-field MRI is effective for pediatric ECMO patients?

Research has shown that using a low-field bedside MRI is safe for children on ECMO, a type of life support. In this trial, all participants will undergo imaging in the Portable MRI Arm. Studies have found that this portable MRI can scan these children without affecting their blood flow or oxygen levels. For example, a study with four children on ECMO confirmed the procedure's safety and effectiveness. The MRI images provided important details about the brain, aiding doctors in monitoring and treating the patients more effectively. Overall, these findings suggest that low-field bedside MRI is a promising tool for safely imaging young patients on ECMO. ^{1 2 6 7 8}

Who Is on the Research Team?

Jessica Wallisch, MD

Principal Investigator

Children's Mercy Kansas City

Are You a Good Fit for This Trial?

This trial is for children and teens (ages 0-17) in intensive care units who are on a life-support technique called ECMO. It's not for those who are pregnant, have devices like pacemakers or metal implants, tattoos with metal ink near the head or neck, suspected metal in their eye, or any MRI-incompatible surgical hardware.

Inclusion Criteria

I am 17 years old or younger.

Children who have been admitted to specific units at Children's Mercy Kansas City.

You are currently using a specific type of life support machine called ECMO.

Exclusion Criteria

Pregnancy

You have any active implanted devices like a pacemaker, defibrillator, insulin pump, or metal objects in your body.

Only implants that are safe to have during an MRI can be considered.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Perform imaging assessments using a low-field bedside MRI system on pediatric and neonatal ECMO patients

1 week

1 visit (in-person)

Post-Intervention

Collect qualitative data from image assessments and analyze critical care therapies conducted during and after the intervention

1 week

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Low-Field Bedside MRI

Trial Overview The study tests the safety and feasibility of using a new low-field MRI machine right at the bedside of young patients on ECMO. The goal is to get clear images of the brain without moving these critically ill patients to standard imaging facilities.

How Is the Trial Designed?

Group I: Portable MRI Arm Experimental Treatment 1 Intervention

All subjects enrolled with be assigned to Arm 1

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

Published Research Related to This Trial

Bedside low-field MRI has been successfully performed on four pediatric patients undergoing extracorporeal life support (ECLS), demonstrating its safety and feasibility in unstable conditions.

This advancement allows for high-quality neuroimaging that can inform treatment decisions, potentially leading to better outcomes for critically ill pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of bedside portable MRI in neonates and children during ECLS. Sabir, H., Kipfmueller, F., Bagci, S., et al.[2023]

In a pilot study of 29 neonatal and pediatric patients supported by ECMO, 34% exhibited developmental delays, with a significant correlation between MRI abnormalities and these delays, particularly in newborns.

Younger patients placed on ECMO had a higher risk of impaired neurodevelopmental outcomes, suggesting that post-ECMO MRI assessments should be standard practice to predict and improve long-term developmental results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurodevelopmental Outcomes in Extracorporeal Membrane Oxygenation Patients: A Pilot Study. Dhar, AV., Scott, S., Anton-Martin, P., et al.[2021]

A study involving 60 infants in a neonatal intensive care unit (NICU) demonstrated that point-of-care 1-Tesla MRI can effectively identify significant intracranial pathologies, such as ischemic lesions and microhemorrhages, which are crucial for timely medical intervention.

While the 1-Tesla MRI had limitations compared to higher-field strength MRIs (like 3-Tesla), it still provided valuable diagnostic information that was not visible on transcranial ultrasound, highlighting its potential utility in NICU settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 1-Tesla MRI system for dedicated brain imaging in the neonatal intensive care unit. Berson, ER., Mozayan, A., Peterec, S., et al.[2023]

Ferumoxytol-enhanced cardiac MRI can be safely performed without anesthesia in neonates and young infants, showing a low need for additional imaging (only 4.8% of cases required further diagnostics).

The 4D flow MRI technique was found to be significantly better than MR angiography for assessing various cardiac structures, indicating its potential as a superior imaging method for complex congenital heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of ferumoxytol-enhanced neonatal and young infant cardiac MRI without general anesthesia. Lai, LM., Cheng, JY., Alley, MT., et al.[2018]

This study is the first to demonstrate that MRI can be safely performed during extracorporeal membrane oxygenation (ECMO) without adversely affecting the ECMO system, as shown in a healthy pig model.

MRI provides high-quality anatomical and functional images of the brain and thoracic vessels, suggesting its potential for early diagnosis of cerebral complications and for research on brain perfusion during ECMO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI of the brain and thorax during extracorporeal membrane oxygenation: preliminary report from a pig model. Lidegran, MK., Frenckner, BP., Mosskin, M., et al.[2016]

Cardiac MRI is safe for critically ill infants with congenital heart disease, showing low risk and minimal hemodynamic changes during the procedure, as evidenced by a study of 20 patients in the pediatric cardiac intensive care unit.

The imaging provided crucial information that led to surgical or catheter interventions in 70% of the cases, highlighting its clinical utility in guiding management decisions for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular magnetic resonance imaging for intensive care infants: safe and effective? Sarikouch, S., Schaeffler, R., Körperich, H., et al.[2021]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.069187

Results From the Multicenter SAFE MRI ECMO Study Our study demonstrates that ULF-pMRI can be performed in patients on ECMO across different ECMO cannulation strategies in specially trained intensive care ...

2. medimaging.net medimaging.net/mri/articles/294796774/worlds-first-studies-with-bedside-portable-mri-in-pediatric-ecmo-patients-demonstrate-safety-and-efficacy.html

World's First Studies with Bedside Portable MRI in ... The findings of the successful, innovative study of the first four pediatric ECMO patients using the mobile MRI suggest that the scan can be performed safely ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11833774/

Neuromonitoring of pediatric and adult extracorporeal ... A study done by Cho et al. demonstrated the safety and feasibility of imaging 3 ECMO patients at the bedside with 0.064T MRI. MRI images were able to detect ...

4. medrxiv.org medrxiv.org/content/10.1101/2025.05.12.25327194v1

Ultralow-field portable MRI feasibility and safety in pediatric ... Pediatric ECMO patients tolerate bedside MRI without clinically significant changes in ECMO flows, perfusion, or oxygenation. What are the ...

5. withpower.com withpower.com/trial/phase-brain-injuries-7-2023-a42c0

Low-Field MRI for Pediatric ECMO Patients The primary object of the study is to further characterize safety and feasibility of low-field bedside MRI in pediatric and neonatal ECMO patients.

6. medrxiv.org medrxiv.org/content/medrxiv/early/2025/05/13/2025.05.12.25327194.full.pdf

Ultralow-field portable MRI feasibility and safety in pediatric ... Data on ECMO variables, time for patient positioning and scan,. MRI sequences, concurrent critical care equipment, changes in ECMO flow and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10071221/

Feasibility of bedside portable MRI in neonates and children ... We present the first four patients receiving bedside high-quality MRI during ECLS treatment. We show that it is safe and feasible to perform bedside MRI in ...

8. mdpi.com mdpi.com/2075-4418/12/11/2871

Safety of Bedside Portable Low-Field Brain MRI in ECMO ... Our preliminary results suggest that adult VA-ECMO patients with IABP support can be safely imaged with low-field POC brain MRI in the intensive care unit.