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Recruiting NCT06469801

NCT06469801 ECMO ABI Detection With Hyperfine

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Clinical Trial Summary
NCT ID NCT06469801
Status Recruiting
Phase
Sponsor Children's Mercy Hospital Kansas City
Condition Acute Brain Injury
Study Type INTERVENTIONAL
Enrollment 30 participants
Start Date 2024-07-23
Primary Completion 2027-06-30

Eligibility & Interventions

Sex All sexes
Min Age 0 Days
Max Age 17 Years
Study Type INTERVENTIONAL
Interventions
Hyperfine

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 30 participants in total. It began in 2024-07-23 with a primary completion date of 2027-06-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The primary objective is to characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support. The secondary objective is to 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.

Eligibility 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

Contact & Investigator

Central Contact

Maura Sien, MSML, CCRC

✉ mesien@cmh.edu

📞 8163028311

Principal Investigator

Jessica Wallisch, MD

PRINCIPAL INVESTIGATOR

Children's Mercy Kansas City

Frequently Asked Questions

Who can join the NCT06469801 clinical trial?

This trial is open to participants of all sexes, aged 0 Days or older, up to 17 Years, studying Acute Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06469801 currently recruiting?

Yes, NCT06469801 is actively recruiting participants. Contact the research team at mesien@cmh.edu for enrollment information.

Where is the NCT06469801 trial being conducted?

This trial is being conducted at Kansas City, United States.

Who is sponsoring the NCT06469801 clinical trial?

NCT06469801 is sponsored by Children's Mercy Hospital Kansas City. The principal investigator is Jessica Wallisch, MD at Children's Mercy Kansas City. The trial plans to enroll 30 participants.

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