Hyperfine MRI for Detecting Brain Injury in Pediatric ECMO Patients

N/A

Recruiting

Led By Jessica Wallisch, MD

Research Sponsored by Children's Mercy Hospital Kansas City

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects admitted to the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or the Neonatal Intensive Care Unit

Ages 0-17 years

Must not have

Former or current welders, metal workers, or individuals with a metal injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of ecmo treatment period, an average of <2 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study how often and what type of brain injuries occur in children who need ECMO support. They will use a special MRI machine to track the brain injuries over time and compare them to

Who is the study for?

This trial is for pediatric patients aged 0-17 years who are receiving ECMO support due to conditions like brain injury from lack of oxygen, stroke, or trauma. They must be in the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or Neonatal Intensive Care Unit.

What is being tested?

The study aims to use a portable MRI device called Hyperfine to detect acute brain injuries (ABI) in children on ECMO support. It will track how often and when these injuries occur during treatment compared with routine care imaging.

What are the potential side effects?

Since this trial involves diagnostic imaging rather than medication or invasive procedures, direct side effects from the intervention (Hyperfine MRI) are minimal to none.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child is in the ICU, CICU, or NICU.

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I am 17 years old or younger.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have worked as a welder, metal worker, or have had a metal injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration of ecmo treatment period, an average of <2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~duration of ecmo treatment period, an average of <2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of ecmo treatment period, an average of <2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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.