ECMO ABI Detection With Hyperfine

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
Children's Mercy Hospital Kansas City
Study ID
NCT06469801
Status
Recruiting
Apply to this trial

Conditions

  • Acute Brain Injury
  • Extracorporeal Membrane Oxygenation Complication
  • Hypoxia-Ischemia, Brain
  • Stroke, Acute

Eligibility Criteria

Sex
ALL
Age
0 Days - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Hyperfine — DEVICE
    Enrolled subjects will undergo a Hyperfine MRI exam, which is a portable, low-field MRI, at various timepoints during their clinical course on ECMO. Patients will undergo imaging within 36 hours of ECMO initiation/cannulation. Patients that remain on ECMO will have repeat imaging at 72-120 hours of ECMO therapy and again weekly for the duration of their ECMO course. Patients will also undergo a portable MRI within 24 hours of clinical head imaging, if applicable.

Study Details

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.

Key Dates

Start date
Jul 23, 2024
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Portable MRI Arm
    All subjects enrolled will be assigned to Arm 1

Primary Outcome Measure

Characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support. [ Time Frame: Duration of ECMO treatment period, an average of <2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's MercyKansas CityMissouri64108
Maura Sien, RT(R), CCRC
[email protected]
Jessica Wallisch, MD
[email protected]

Find similar trials in Kansas City, MO

By research site
Children's Mercy· Kansas City, MO

Related Studies