Clinical trial NCT05041712: Biomarkers of Brain Injury in Critically-Ill Children on Extracorporeal Membrane Oxygenation
Official title: Biomarkers of Brain Injury in Critically-Ill Children on Extracorporeal Membrane Oxygenation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extracorporeal Membrane Oxygenation
Children
Neurologic Injury
Keywords: Brain Injury Biomarkers
Neurodevelopmental Outcomes
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2021-09-13
Enrollment: 455
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 225 children who are cannulated onto ECMO and admitted to a pediatric or cardiac Intensive Care Unit at participating institutions.

Brief 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.

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.

Primary outcomes:
measure: Change in Vineland Adaptive Behavior Scales-Third Edition (VABS-3)
timeFrame: Baseline and 18 months post-ECMO
Secondary outcomes:
measure: Change in Functional Status Scale (FSS)
timeFrame: Baseline and at hospital discharge, up to 18 months post-ECMO
measure: Change in Pediatric Cerebral Performance Category (PCPC)
timeFrame: Baseline and at hospital discharge, up to 18 months post-ECMO
measure: Change in Pediatric Overall Performance Category (POPC)
timeFrame: Baseline and at hospital discharge, up to 18 months post-ECMO
measure: Change in Pediatric Quality of Life (PedsQL) Inventory
timeFrame: Baseline and 18 months post-ECMO
measure: Consumer Assessment of Healthcare Providers and Systems (CAHPS) Child Survey 5.0H with the Children with Chronic Conditions (CCC) Item Set
timeFrame: 18 months post-ECMO
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Johns Hopkins University
name: Melanie Bembea, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: