Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Approaches and Decisions for Acute Pediatric TBI Trial
NCT04077411 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 1,082 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04077411 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Massachusetts, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04077411?
The interventions under investigation include: Observational (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04077411?
This trial is sponsored by University of Pittsburgh, which has 1,082 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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