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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

Active, not recruiting

Detailed Description

The specific aims are to: 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). 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. 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

March 20, 2024

Principal Investigator

Kerri LaRovere

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

Primary Contact Information

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.

For more information on this trial, visit clinicaltrials.gov.

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