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NCT04077411 · ClinicalTrials.gov registry record
Approaches and Decisions for Acute Pediatric TBI Trial
A clinical trial of Severe Traumatic Brain Injury, sponsored by University of Pittsburgh.
- Completed
- Registry status
- 1,000
- Enrollment target
- 20
- Study locations
NCT04077411 is a study of Severe Traumatic Brain Injury that has completed, run by University of Pittsburgh. The registered enrollment target is 1,000 participants. The trial reports 20 study locations across 15 states.
The verdict
NCT04077411, a study of Severe Traumatic Brain Injury, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- 1,000 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- OTHER Observational
Study Locations (20)
California
- University of California, San Diego / Rady's Children's Hospital - La Jolla
- Children's Hospital of Los Angeles - Los Angeles
- UCLA Mattel Children's Hospital - Los Angeles
- UC Davis Medical Center - West Sacramento
Massachusetts
- Massachusetts General Hospital - Boston
- Boston Children's Hospital / Harvard University - Boston
Ohio
- University of Cincinnati / Cincinnati Children's Hospital Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
Alabama
- Children's Hospital of Alabama - Birmingham
Arizona
- Phoenix Children's Hospital - Phoenix
Colorado
- Children's Hospital Colorado - Denver
District of Columbia
- Children's National Medical Center - Washington D.C.
Florida
- Miami Children's Hospital - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2014-02-20 |
| Est. Completion | 2018-08-28 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04077411
The ClinicalTrials.gov registry entry for NCT04077411 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Severe Traumatic Brain Injury appearing as the primary indexed condition, and to 1 intervention - of which Observational is the first listed.
NCT04077411 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Massachusetts, Ohio.
Frequently Asked Questions
What is clinical trial NCT04077411 about?
NCT04077411 is a clinical study titled "Approaches and Decisions for Acute Pediatric TBI Trial". 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 mo...
What is the current status of trial NCT04077411?
This trial is currently completed. The enrollment target is 1,000 participants. The study started on 2014-02-20. Estimated completion is 2018-08-28.
What conditions does trial NCT04077411 study?
This clinical trial studies the following conditions: Severe Traumatic Brain Injury.
What interventions are being tested in trial NCT04077411?
The interventions under investigation include: Observational (OTHER).
Who is sponsoring clinical trial NCT04077411?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04077411 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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