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

Active, not recruiting

• Conditions: Children; Neurologic Injury; Extracorporeal Membrane Oxygenation

• Registration Number: NCT05041712
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study Start: 2019-12-06
• Study First Submitted: 2021-08-10
• Study First Submitted QC: 2021-09-08
• Study First Posted: 2021-09-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 625

Inclusion Criteria

• Children (2 days to <18 years) cannulated onto ECMO and admitted to a pediatric or cardiac Intensive Care Unit at participating institutions.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Vineland Adaptive Behavior Scales-Third Edition (VABS-3)	Baseline and 18 months post-ECMO	VABS-3 is a 381-item caregiver report measure that was developed to assess adaptive behavior. The questionnaire is divided into 4 domains of adaptive behavior: 1) communication, 2) daily living, 3) social skills and relationships, and 4) physical activity. Each item is rated 0 (never), 1 (sometimes), or 2 (usually or often) as how often the child does the behavior independently without help or reminders. The overall adaptive composite score has a mean of 100 and standard deviation of 15 with lower scores indicating worse intellectual disability.

Secondary Outcome Measures

Name	Time	Method
Change in Pediatric Cerebral Performance Category (PCPC)	Baseline and at hospital discharge, up to 18 months post-ECMO	PCPC consists of a 6-point scale: 1) normal; 2) mild disability; 3) moderate disability; 4) severe disability; 5) coma/vegetative state; 6) brain death. Higher scores indicating worse performance or functional morbidity
Change in Functional Status Scale (FSS)	Baseline and at hospital discharge, up to 18 months post-ECMO	The FSS examines 6 domains of functioning: 1) mental status; 2) sensory; 3) communication; 4) motor function; 5) feeding; and 6) respiratory and each domain receives a score of 1 (normal), 2 (mild dysfunction), 3 (moderate dysfunction), 4 (severe dysfunction), or 5 (very severe dysfunction). Final scores range from 6 to 30 with higher scores indicating greater dysfunction.
Consumer Assessment of Healthcare Providers and Systems (CAHPS) Child Survey 5.0H with the Children with Chronic Conditions (CCC) Item Set	18 months post-ECMO	The CAHPS CCC is an 81-item questionnaire that provides information on parents' experiences with their child's health care and gives a general indication of how well the health care meets their expectations. Five CCC-specific results are calculated for each population: 1) access to specialized services, 2) family-centered care: personal doctor who knows the child, 3) coordination of care for children with chronic conditions, 4) access to prescription medication, and 5) family-centered care: getting needed information.
Change in Pediatric Quality of Life (PedsQL) Inventory	Baseline and 18 months post-ECMO	The PedsQL Inventory is a 36-item (for infants 1-12 months), 45 item (for infants 13-24 months) or 23-item (children 2-18) questionnaire with established validity and reliability for health outcomes measurements in pediatric populations, including former PICU patients. The PedsQL is used as a parent proxy report for all ages, as well as self-report in children between 5 and 18 years. The scales are divided into 4 domains of functioning: 1) physical functioning, 2) emotional functioning, 3) social functioning and either 4) cognitive functioning (on the infant scales) or school functioning (on the child scales). Each item on the parent proxy report receives a score of 0 (never), 1 (almost never), 2 (sometimes), 3 (often), or 4 (almost always). Each score on the child report receives a score of 0 (not at all), 2 (sometimes), or 4 (a lot). Final transformed scores range from 0-100 with higher scores indicating better health-related quality of life.
Change in Pediatric Overall Performance Category (POPC)	Baseline and at hospital discharge, up to 18 months post-ECMO	POPC consists of a 6-point scale: 1) good overall performance; 2) mild overall disability; 3) moderate overall disability; 4) severe overall disability; 5) coma/vegetative state; 6) brain death. Higher scores indicating worse performance or functional morbidity

Trial Locations

Locations (11)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

St. Louis Children's Hospital; 🇺🇸 Saint Louis, Missouri, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

Riley Hospital for Children; 🇺🇸 Indianapolis, Indiana, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

University of Tennessee Health Science Center; 🇺🇸 Memphis, Tennessee, United States