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

NCT05041712 | Completed

• 2 other identifiers: IRB002157941R01NS106292
• Study Type: observational
• Target: 455
• Locations: 1 country
• Sites: 11

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.

Conditions

Extracorporeal Membrane Oxygenation; Children; Neurologic Injury

Keywords

Brain Injury Biomarkers; Neurodevelopmental Outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Functional Status Scale (FSS)

  Baseline and at hospital discharge, up to 18 months post-ECMO

• Change in Pediatric Cerebral Performance Category (PCPC)

  Baseline and at hospital discharge, up to 18 months post-ECMO

• Change in Pediatric Overall Performance Category (POPC)

  Baseline and at hospital discharge, up to 18 months post-ECMO

• Change in Pediatric Quality of Life (PedsQL) Inventory

  Baseline and 18 months post-ECMO

• 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

Study Arms (2)

Case cohort

Observational study of children between the ages of 2 days to \< 18 years who are cannulated onto ECMO at participating sites

Control cohort

Observational study of children between the ages of 2 days to \< 18 years admitted to the Johns Hopkins Pediatric Intensive Care Unit (PICU) or Pediatric Cardiac Intensive Care Unit (PCICU) for any reason.

Eligibility Criteria

• Age: 2 Days - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (11)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20310, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine and ultrafiltrate fluid (if the participant is on renal replacement therapy or ultrafiltration) will be collected daily on ECMO days #1-5, then every 3 days thereafter while on ECMO.

Study Officials

• Melanie Bembea, MD, MPH, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: September 13, 2021
• Study Start: December 6, 2019
• Primary Completion: January 24, 2025
• Study Completion: May 5, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

US (11)