Approaches and Decisions for Acute Pediatric TBI Trial
Completed
Conditions studied: Severe Traumatic Brain Injury
In brief
Approaches and Decisions in Acute Pediatric TBI Trial (ADAPT) is an international research study designed to evaluate the impact of interventions on the outcomes of children with severe traumatic brain injury. Pediatric traumatic brain injury (TBI) is the leading killer of children, resulting in more than 7000 deaths and $2 billion in acute care costs each year. Despite this large burden of disease, advances in the field have been limited due to weak evidenced-based guidelines and the limitations of randomized, controlled trials (RCTs) to demonstrate efficacy of single treatment strategies due to wide treatment variability. ADAPT is a practical study design in a novel approach - an observational cohort study designed to evaluate the association of 6 aspects of pediatric TBI care with outcomes using statistical modeling to correct for confounding variables. Completion of this study will provide compelling evidence to change clinical practices, provide evidence for new Level II recommendations for future guidelines and lead to improved research protocols that would limit variability in TBI treatments - helping children immediately through better clinical practices and ultimately through more effective investigation.
Key facts
- Study ID
- NCT04077411
- Run by
- University of Pittsburgh
- People needed
- 1000
- Starts
- 2014-02-20
- Expected to finish
- 2018-08-28
- Last updated by the study team
- 2023-12-08
Who can join
Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Admission to a study site for treatment of severe traumatic brain injury
- ICP monitor placed as part of the child's standard care
- Glasgow Coma Scale (GCS) ≤ 8 after resuscitation
- Age 0 - 18 y
You may not qualify if…
- 1. ICP Monitor placed at another hospital
- 2. Diagnosis of pregnancy in clinical subject
Where it is running
- Children's Hospital of Alabama — Birmingham, Alabama, United States
- Phoenix Children's Hospital — Phoenix, Arizona, United States
- University of California, San Diego / Rady's Children's Hospital — La Jolla, California, United States
- Children's Hospital of Los Angeles — Los Angeles, California, United States
- UCLA Mattel Children's Hospital — Los Angeles, California, United States
- UC Davis Medical Center — West Sacramento, California, United States
- Children's Hospital Colorado — Denver, Colorado, United States
- Children's National Medical Center — Washington D.C., District of Columbia, United States
- Miami Children's Hospital — Miami, Florida, United States
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States
- University of Iowa Children's Hospita — Iowa City, Iowa, United States
- John Hopkins Children's Center of Baltimore — Baltimore, Maryland, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Boston Children's Hospital / Harvard University — Boston, Massachusetts, United States
- Wayne State University in Detroit / Children's Hospital of Michigan — Detroit, Michigan, United States
- Washington University - St. Louis — St Louis, Missouri, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- Carolinas Medical Center Levine Children's Hospital — Charlotte, North Carolina, United States
- University of Cincinnati / Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- Nationwide Children's Hospital — Columbus, Ohio, United States
- Penn State University - Hershey — Hershey, Pennsylvania, United States
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
- University of Tennessee / Le Bonheur Children's Hospita — Memphis, Tennessee, United States
- UT Southwestern / Children's Medical Center at Dallas — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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