Detecting brain injuries in children on ECMO using portable MRI
Low-Field Bedside MRI for Detection of Acute Brain Injury in Pediatric Extracorporeal Membrane Oxygenation
NA · Children's Mercy Hospital Kansas City · NCT06469801
This study is testing a portable MRI to see if it can help find brain injuries in children on ECMO support more quickly and accurately.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 0 Days to 17 Years |
| Sex | All |
| Sponsor | Children's Mercy Hospital Kansas City (other) |
| Locations | 1 site (Kansas City, Missouri) |
| Trial ID | NCT06469801 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the prevalence and types of acute brain injury (ABI) in pediatric patients who are undergoing extracorporeal membrane oxygenation (ECMO) support. It utilizes an ultralow-field portable MRI system to monitor brain health at the bedside, addressing the limitations of traditional imaging methods that are not compatible with ECMO devices. By evaluating the time course and rates of ABI in relation to ECMO duration and routine clinical imaging, the study seeks to improve early detection and intervention for brain injuries in critically ill children. The research focuses on patients aged 0-17 years who are at high risk for ECMO.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 0-17 years who are admitted to intensive care units and are at high risk for requiring ECMO support.
Not a fit: Patients with active implants incompatible with MRI or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and better management of brain injuries in pediatric patients on ECMO, potentially improving outcomes and reducing morbidity.
How similar studies have performed: While there have been some feasibility studies using portable MRI in adult and pediatric ECMO patients, this specific approach to ABI detection is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * 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 • High risk participants include, but are not limited to: * Undergoing cardiac surgery * Congenital heart disease * Congenital diaphragmatic hernia * Refractory hypoxemic and/or hypercarbic respiratory failure * Vasoactive-refractory shock Exclusion Criteria * Pregnancy * Active implants such as: * Pacemaker * Implanted defibrillator * Implanted insulin pump * Deep brain stimulator * Vagus nerve stimulator * Cochlear implant * Programmable shunt * MRI incompatible surgical hardware (e.g., staples, screws, etc.) * Metal-containing tattoos or permanent make-up on head or neck * Suspected metal in eye, e.g., * Former or current welders, metal workers, or individuals with a metal injury * Metal shrapnel * Passive implants are considered MRI-conditional
Where this trial is running
Kansas City, Missouri
- Children's Mercy — Kansas City, Missouri, United States (RECRUITING)
Study contacts
- Principal investigator: Jessica Wallisch, MD — Children's Mercy Kansas City
- Study coordinator: Maura Sien, MSML, CCRC
- Email: mesien@cmh.edu
- Phone: 8163028311
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Brain Injury, Extracorporeal Membrane Oxygenation Complication, Hypoxia-Ischemia, Brain, Stroke, Acute, Pediatric