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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04077411




Registration number
NCT04077411
Ethics application status
Date submitted
29/08/2019
Date registered
4/09/2019
Date last updated
8/12/2023

Titles & IDs
Public title
Approaches and Decisions for Acute Pediatric TBI Trial
Scientific title
Approaches and Decisions for Acute Pediatric TBI (ADAPT) Trial
Secondary ID [1] 0 0
U01NS081041
Secondary ID [2] 0 0
PRO13020047
Universal Trial Number (UTN)
Trial acronym
ADAPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Traumatic Brain Injury 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Observational

Children with severe TBI - Children with severe Traumatic Brain Injury


Other interventions: Observational
This is an observational study with no interventions.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Glasgow Outcome Score - Extended Pediatrics
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
- 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
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 1. ICP Monitor placed at another hospital

- 2. Diagnosis of pregnancy in clinical subject

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/08/2018
Sample size
Target
Accrual to date
Final
1000
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Children's Health Queensland Hospital and Health Service - Brisbane
Recruitment hospital [2] 0 0
Royal Children's Hospital - Melbourne
Recruitment hospital [3] 0 0
Princess Margaret Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
6008 - Perth
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Colorado
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District of Columbia
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Florida
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Georgia
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Iowa
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Maryland
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Massachusetts
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Michigan
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Missouri
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Nebraska
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North Carolina
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Ohio
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Pennsylvania
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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United States of America
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Wisconsin
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India
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New Delhi
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Netherlands
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Rotterdam
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New Zealand
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Auckland
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South Africa
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Cape Town
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Spain
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Barcelona
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United Kingdom
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Birmingham
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United Kingdom
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Bristol
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United Kingdom
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Cambridge
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United Kingdom
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Leeds
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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Newcastle upon Tyne
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United Kingdom
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Southampton
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United Kingdom
State/province [36] 0 0
Victoria

Funding & Sponsors
Primary sponsor type
Other
Name
University of Pittsburgh
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Neurological Disorders and Stroke (NINDS)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04077411
Trial related presentations / publications
Sarnaik A, Ferguson NM, O'Meara AMI, Agrawal S, Deep A, Buttram S, Bell MJ, Wisniewski SR, Luther JF, Hartman AL, Vavilala MS; Investigators of the ADAPT Trial. Age and Mortality in Pediatric Severe Traumatic Brain Injury: Results from an International Study. Neurocrit Care. 2018 Jun;28(3):302-313. doi: 10.1007/s12028-017-0480-x.
Bell MJ, Adelson PD, Wisniewski SR; Investigators of the ADAPT Study,. Challenges and opportunities for pediatric severe TBI-review of the evidence and exploring a way forward. Childs Nerv Syst. 2017 Oct;33(10):1663-1667. doi: 10.1007/s00381-017-3530-y. Epub 2017 Sep 6.
Miller Ferguson N, Sarnaik A, Miles D, Shafi N, Peters MJ, Truemper E, Vavilala MS, Bell MJ, Wisniewski SR, Luther JF, Hartman AL, Kochanek PM; Investigators of the Approaches and Decisions in Acute Pediatric Traumatic Brain Injury (ADAPT) Trial. Abusive Head Trauma and Mortality-An Analysis From an International Comparative Effectiveness Study of Children With Severe Traumatic Brain Injury. Crit Care Med. 2017 Aug;45(8):1398-1407. doi: 10.1097/CCM.0000000000002378.
Larsen GY, Schober M, Fabio A, Wisniewski SR, Grant MJ, Shafi N, Bennett TD, Hirtz D, Bell MJ. Structure, Process, and Culture Differences of Pediatric Trauma Centers Participating in an International Comparative Effectiveness Study of Children with Severe Traumatic Brain Injury. Neurocrit Care. 2016 Jun;24(3):353-60. doi: 10.1007/s12028-015-0218-6.
Public notes

Contacts
Principal investigator
Name 0 0
Michael J Bell, MD
Address 0 0
University of Pittsburgh Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04077411