Recruiting

ECMO with Hyperfine

Sponsor:

Children's Mercy Hospital Kansas City

Code:

NCT06469801

Conditions

Acute Brain Injury

Extracorporeal Membrane Oxygenation Complication

Hypoxia-Ischemia, Brain

Stroke, Acute

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Hyperfine

Study Details

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.

Conditions

Acute Brain Injury

Extracorporeal Membrane Oxygenation Complication

Hypoxia-Ischemia, Brain

Stroke, Acute

Study ID

NCT06469801

Start date

Jul 23, 2024

Status verified date

Aug, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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
  • Any patient who has a contraindication to having an MRI
  • Patients with a passive or active implant will:

  • First be reviewed on MRISafety.com to determine MR conditionality
  • If device is listed as Conditional or Unsafe for a 1.5T or a 3T, device will then be reviewed by MRI Safety Officer or MRI Physician Section chief to determine true conditionality for the portable MRI

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Portable MRI Arm

All subjects enrolled will be assigned to Arm 1

Interventions

Hyperfine

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.

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 and Locations

Central contacts

Maura Sien, MSML, CCRC

8163028311mesien@cmh.edu

Locations

Children's Mercy

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Maura Sien, RT(R), CCRC

mesien@cmh.edu

Jessica Wallisch, MD

jwallisch@cmh.edu

More Information

Sponsor

Children's Mercy Hospital Kansas City

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • Pediatric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Mercy Hospital Kansas City on 2026-08-11.