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

Johns Hopkins University

Status: Active, not recruiting

Conditions: Neurologic Injury; Children; Extracorporeal Membrane Oxygenation

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05041712

1R01NS106292 (U.S. NIH Grant/Contract)

IRB00215794

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 625 estimated patients

Sex: All

Ages: 2 days to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

625 participants in 2 patient groups

Case cohort

Description:

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

Control cohort

Description:

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.