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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary object of the study is to further characterize safety and feasibility of low-field bedside MRI in pediatric and neonatal ECMO patients. To perform imaging assessments of an early-stage magnetic resonance imaging (MRI) system on patients using low field magnetic strength. Collect qualitative data from the image assessments to optimize device performance using a low field magnetic resonance imaging device in a simulated use environment; Collect qualitative data from the image assessments using a high field magnetic resonance imaging, computed tomography and ultrasound devices. Generate anonymized image data for post-acquisition evaluation, performance measuring and planning for subsequent study size

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 data supports the effectiveness of the treatment Low-Field Bedside MRI for pediatric ECMO patients?

Research shows that Low-Field MRI is a safe and feasible way to get high-quality images of the brain in children who are too unstable to be moved to a traditional MRI machine. This can help doctors make better treatment decisions for children on ECMO (a machine that helps with breathing and heart function). ^{1 2 3 4 5}

Is Low-Field MRI safe for pediatric patients?

Research shows that Low-Field MRI is safe for use in pediatric patients, including those who are critically ill, as it can be performed at the bedside without needing to move unstable patients. This has been demonstrated in studies where children safely underwent MRI while receiving intensive care treatments. ^{1 6 7 8 9}

How does low-field MRI differ from other treatments for pediatric ECMO patients?

Low-field MRI is unique because it allows for bedside imaging of pediatric ECMO patients, which is often not feasible with standard MRI due to patient instability and equipment limitations. This approach provides high-quality images that can guide treatment decisions without needing to move the patient to a separate imaging facility. ^{1 2 5 8 9}

Research Team

Jessica Wallisch, MD

Principal Investigator

Children's Mercy Kansas City

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Feasibility of bedside portable MRI in neonates and children during ECLS. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

MRI of the brain and thorax during extracorporeal membrane oxygenation: preliminary report from a pig model. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Extracorporeal membrane oxygenation in infants: angiographic and parenchymal evaluation of the brain with MR imaging. [2004]

4. United States pubmed.ncbi.nlm.nih.gov

Neurodevelopmental Outcomes in Extracorporeal Membrane Oxygenation Patients: A Pilot Study. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Investigation of lung disease in preterm infants using magnetic resonance imaging. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Anaesthesia for critically ill children during magnetic resonance imaging. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular magnetic resonance imaging for intensive care infants: safe and effective? [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Feasibility of ferumoxytol-enhanced neonatal and young infant cardiac MRI without general anesthesia. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

A 1-Tesla MRI system for dedicated brain imaging in the neonatal intensive care unit. [2023]