CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,000 enrolled
Drug / intervention
Observationalother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04077411
NCT04077411N/ACompleted

Approaches and Decisions for Acute Pediatric TBI (ADAPT) Trial

University of Pittsburgh·observational·Posted Sep 4, 2019·Updated Dec 8, 2023

In Brief

An observational study evaluating Observational for Severe Traumatic Brain Injury. Completed, enrolled 1,000 participants across 48 sites in 8 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, India, Netherlands, New Zealand, South Africa, Spain, United Kingdom, United States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 4, 2019
Enrollment StartFeb 20, 2014
Primary CompletionSep 26, 2016
Study CompletionAug 28, 2018
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 6.8 years ago

Interventions

Observationalother

This is an observational study with no interventions.