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

Children Clinical Trial

— BEAM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05041712
• Other study ID #: IRB00215794
• Secondary ID: 1R01NS106292
• Status: Active, not recruiting
• Start date: December 6, 2019
• Est. completion date: May 2025

Study information

• Verified date: March 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 625
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Gender: All
• Age group: 2 Days to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Children
• Extracorporeal Membrane Oxygenation
• Neurologic Injury
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Texas Children's Hospital	Houston	Texas
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	University of California Los Angeles	Los Angeles	California
United States	University of Tennessee Health Science Center	Memphis	Tennessee
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	Seattle Children's Hospital	Seattle	Washington
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Vineland Adaptive Behavior Scales-Third Edition (VABS-3)	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.	Baseline and 18 months post-ECMO
Secondary	Change in Functional Status Scale (FSS)	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.	Baseline and at hospital discharge, up to 18 months post-ECMO
Secondary	Change in Pediatric Cerebral Performance Category (PCPC)	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	Baseline and at hospital discharge, up to 18 months post-ECMO
Secondary	Change in Pediatric Overall Performance Category (POPC)	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	Baseline and at hospital discharge, up to 18 months post-ECMO
Secondary	Change in Pediatric Quality of Life (PedsQL) Inventory	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.	Baseline and 18 months post-ECMO
Secondary	Consumer Assessment of Healthcare Providers and Systems (CAHPS) Child Survey 5.0H with the Children with Chronic Conditions (CCC) Item Set	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.	18 months post-ECMO