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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NS106292 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
The specific aims are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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225 children who are cannulated onto ECMO and admitted to a pediatric or cardiac Intensive Care Unit at participating institutions.
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| Name | Affiliation | Role |
|---|---|---|
| Melanie Bembea, MD, MPH, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States | ||
| University of California Los Angeles |
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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.
| 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 | 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 | 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. | 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. | 18 months post-ECMO |
| Los Angeles |
| California |
| 90095 |
| United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20310 | United States |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| University of Tennessee Health Science Center | Memphis | Tennessee | 38163 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |