Extracorporeal Membrane OxygenationBEAMNCT05041712
Biomarkers of Brain Injury in Critically-Ill Children on Extracorporeal Membrane Oxygenation
An observational study of Extracorporeal Membrane Oxygenation and Children, run by Johns Hopkins University at 11 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 2 days to 18 years
- Conditions the study is for
- Extracorporeal Membrane Oxygenation, Children, Neurologic Injury
- How many people
- 455 participants
- Where
- 11 sitesUnited States
- Study dates
- 6 Dec 2019to 5 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 days to 18 years
- All sexes
- Child, Adult
Study population: 225 children who are cannulated onto ECMO and admitted to a pediatric or cardiac Intensive Care Unit at participating institutions.
Who may be able to join
- Children (2 days to <18 years) cannulated onto ECMO and admitted to a pediatric or cardiac Intensive Care Unit at participating institutions.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Boston Children's Hospital
Boston, Massachusetts, 02115
Texas Children's Hospital
Houston, Texas, 77030
Riley Hospital for Children
Indianapolis, Indiana, 46202
Children's Hospital Los Angeles
Los Angeles, California, 90027
University of California Los Angeles
Los Angeles, California, 90095
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Seattle Children's Hospital
Seattle, Washington, 98105
St. Louis Children's Hospital
St Louis, Missouri, 63110
Children's National Medical Center
Washington D.C., District of Columbia, 20310
About this study
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.
Read the 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.
- Keywords
- Brain Injury Biomarkers, Neurodevelopmental Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 18 months post-ECMO
Secondary outcomes (5)
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.
Measured: Baseline and at hospital discharge, up to 18 months post-ECMO
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
Measured: Baseline and at hospital discharge, up to 18 months post-ECMO
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
Measured: Baseline and at hospital discharge, up to 18 months post-ECMO
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.
Measured: 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
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.
Measured: 18 months post-ECMO
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start6 Dec 2019
- Primary completion24 Jan 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane OxygenationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melanie Bembea, MD, MPH, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041712
- Sponsor's protocol ID
- IRB00215794
- Other IDs
- 1R01NS106292
- Acronym
- BEAM
- Status last verified
- May 2025
- First submitted
- 10 Aug 2021
- Last updated
- 4 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Brain Injury in Critically-Ill Children on Extracorporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT05041712
- Acronym / sponsor ID
- BEAM / IRB00215794
- Keywords
- Brain Injury Biomarkers, Neurodevelopmental Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 days to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- 225 children who are cannulated onto ECMO and admitted to a pediatric or cardiac Intensive Care Unit at participating institutions.
Key inclusion criteria (1 listed)
- Children (2 days to <18 years) cannulated onto ECMO and admitted to a pediatric or cardiac Intensive Care Unit at participating institutions.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Vineland Adaptive Behavior Scales-Third Edition (VABS-3)
Time frame: 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.
5 secondary outcomes
Change in Functional Status Scale (FSS)
Time frame: Baseline and at hospital discharge, up to 18 months post-ECMO
Change in Pediatric Cerebral Performance Category (PCPC)
Time frame: Baseline and at hospital discharge, up to 18 months post-ECMO
Change in Pediatric Overall Performance Category (POPC)
Time frame: Baseline and at hospital discharge, up to 18 months post-ECMO
Change in Pediatric Quality of Life (PedsQL) Inventory
Time frame: 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
Time frame: 18 months post-ECMO
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Drug Effect
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Bembea, MD, MPH, PhD principal investigator
Johns Hopkins University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extracorporeal Membrane Oxygenation and Children, run by Johns Hopkins University at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vineland Adaptive Behavior Scales-Third Edition (VABS-3) (time frame: Baseline and 18 months post-ECMO). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.