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.

Conditions

  • Extracorporeal Membrane Oxygenation
  • Children
  • Neurologic Injury

Recruitment Status

COMPLETED

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.

Eligibility Criteria

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.

Gender

ALL

Min Age

2 Days

Max Age

18 Years

Download Date

2025-06-04

Principal Investigator

Kerri LaRovere

This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.

Primary Contact Information

Contact Info
Kerri LaRovere, MD
kerri.larovere@childrens.harvard.edu
857-218-5466

This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.

Contact

For more information and to contact the study team:

Biomarkers of Brain Injury in Critically-Ill Children on Extracorporeal Membrane Oxygenation NCT05041712 Kerri LaRovere, MD kerri.larovere@childrens.harvard.edu 857-218-5466