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Approaches and Decisions for Acute Pediatric TBI Trial

NCT04077411 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2023-12-08

No results posted yet for this 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

  • Severe Traumatic Brain Injury

Interventions

OTHER

Observational

This is an observational study with no interventions.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Michael J Bell, MD · University of Pittsburgh Medical Center

  • Stephen R Wisniewski, PhD · University of Pittsburgh

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-20
Primary Completion
2016-09-26
Completion
2018-08-28

Countries

  • United States
  • Australia
  • India
  • Netherlands
  • New Zealand
  • South Africa
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04077411 on ClinicalTrials.gov