Summary

Eligibility
for people ages up to 18 years (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

Summary

The BEAM study is a multicenter, prospective, observational study in children supported on extracorporeal membrane oxygenation (ECMO). The primary goals of this study are to develop and refine a brain injury multimarker panel for accurate neurologic monitoring at the bedside and early classification of mortality and disability outcomes of critically ill children supported on ECMO.

Details

The specific aims are to:

  1. Determine if circulating levels of brain injury markers during ECMO and brain MRI abnormalities within 6 weeks after ECMO are associated with survival at 18 months after ECMO with a score ≥85 on the Vineland Adaptive Behavior Scales, third edition (VABS-III).
  2. Determine whether the presence and degree of inflammation during ECMO and markers of neuroinflammation on brain magnetic resonance spectroscopy (MRS) within 6 weeks after ECMO are associated with survival at 18 months after ECMO with a score ≥85 on VABS-III.
  3. Determine whether metabolic and lipid neuroinflammatory pathways will distinguish between at-risk for, acute, and recovery phases of neurologic injury (NI) during ECMO.

Keywords

Extracorporeal Membrane Oxygenation, Children, Neurologic Injury, Brain Injury Biomarkers, Neurodevelopmental Outcomes, Brain Injuries, Wounds and Injuries

Eligibility

You can join if…

Open to people ages up to 18 years

  • Children (2 days to <18 years) cannulated onto ECMO and admitted to a pediatric or cardiac Intensive Care Unit at participating institutions.

You CAN'T join if...

  • ECMO cannulation at an outside institution with transport to a study site >24 hours after ECMO initiation
  • Limitation of care (e.g., family planning to withdraw support)
  • Brain death evaluation within 24 hours of ECMO cannulation
  • Inability to speak or understand English or Spanish
  • Pregnancy.

Locations

  • University of California Los Angeles
    Los Angeles California 90095 United States
  • Children's Hospital Los Angeles
    Los Angeles California 90027 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Johns Hopkins University
ID
NCT05041712
Study Type
Observational
Participants
Expecting 625 study participants
Last Updated