Biomarkers of Brain Injury in Critically-Ill Children on Extracorporeal Membrane Oxygenation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

455 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-06

Study Completion Date

2025-05-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Extracorporeal Membrane Oxygenation Children Neurologic Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Case cohort

Observational study of children between the ages of 2 days to \< 18 years who are cannulated onto ECMO at participating sites

No interventions assigned to this group

Control cohort

Observational study of children between the ages of 2 days to \< 18 years admitted to the Johns Hopkins Pediatric Intensive Care Unit (PICU) or Pediatric Cardiac Intensive Care Unit (PCICU) for any reason.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.

Minimum Eligible Age

2 Days

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No