NCT05041712

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 455 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 2 Days – 18 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Extracorporeal Membrane Oxygenation
• Children
• Neurologic Injury

Timeline

• Start date: 2019-12-06
• Primary completion: 2025-01-24
• Completion: 2025-05-05
• First posted: 2021-09-13
• Last updated: 2025-06-04

Locations

11 sites across 1 country: United States