Approaches and Decisions for Acute Pediatric TBI Trial
ADAPT
2 other identifiers
observational
1,000
8 countries
48
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2014
Longer than P75 for all trials
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2018
CompletedFirst Submitted
Initial submission to the registry
August 29, 2019
CompletedFirst Posted
Study publicly available on registry
September 4, 2019
CompletedDecember 8, 2023
March 1, 2023
2.6 years
August 29, 2019
December 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glasgow Outcome Score - Extended Pediatrics
Physician-rated assessment of functional outcome. Problems in functioning should have deteriorated from premorbid level. The categories are: 8 - Death 7 - Vegetative State (VS) 6 - Lower Severe Disability (Lower SD) 5 - Upper Severe Disability (Upper SD) 4 - Lower Moderate Disability (Lower MD) 3 - Upper Moderate Disability (Upper MD) 2 - Lower Good Recovery (Lower GR) 1 - Upper Good Recovery (Upper GR)
6 months
Study Arms (1)
Children with severe TBI
Children with severe Traumatic Brain Injury
Interventions
Eligibility Criteria
Children with severe traumatic brain injury (TBI)
You may qualify if:
- 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
You may not qualify if:
- \. ICP Monitor placed at another hospital
- \. Diagnosis of pregnancy in clinical subject
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Children's Hospital of Alabama
Birmingham, Alabama, 35294, United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
University of California, San Diego / Rady's Children's Hospital
La Jolla, California, 92093, United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
UCLA Mattel Children's Hospital
Los Angeles, California, 90095, United States
UC Davis Medical Center
West Sacramento, California, 95798, United States
Children's Hospital Colorado
Denver, Colorado, 80045, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Miami Children's Hospital
Miami, Florida, 33155, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
University of Iowa Children's Hospita
Iowa City, Iowa, 52252, United States
John Hopkins Children's Center of Baltimore
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02241, United States
Boston Children's Hospital / Harvard University
Boston, Massachusetts, 414413, United States
Wayne State University in Detroit / Children's Hospital of Michigan
Detroit, Michigan, 13201, United States
Washington University - St. Louis
St Louis, Missouri, 63112, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Carolinas Medical Center Levine Children's Hospital
Charlotte, North Carolina, 28260, United States
University of Cincinnati / Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Nationwide Children's Hospital
Columbus, Ohio, 43271, United States
Penn State University - Hershey
Hershey, Pennsylvania, 17033, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19178, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15213, United States
University of Tennessee / Le Bonheur Children's Hospita
Memphis, Tennessee, 38163, United States
UT Southwestern / Children's Medical Center at Dallas
Dallas, Texas, 75284, United States
Texas Children's Hospital (Baylor College of Medicine)
Houston, Texas, 77030, United States
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
Children's Hospital of Richmond at VCU
Richmond, Virginia, 23298, United States
University of Washington - Seattle
Seattle, Washington, 98185, United States
University of Wisconsin - Madison
Madison, Wisconsin, 53715, United States
Children's Health Queensland Hospital and Health Service
Brisbane, Australia
Royal Children's Hospital
Melbourne, Australia
Princess Margaret Hospital
Perth, 6008, Australia
All India Institute of Medical Sciences
New Delhi, 110029, India
Erasmus Medical Center Children's Hospital
Rotterdam, 3015 GJ, Netherlands
Starship Children's Hospital
Auckland, New Zealand
University of Cape Town
Cape Town, South Africa
Hospital Vall d'Hebron
Barcelona, Spain
Birmingham Children's Hospita
Birmingham, 6NH, United Kingdom
University Hospitals Bristol
Bristol, United Kingdom
Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
Leeds Teaching Hospital
Leeds, LS 7TF, United Kingdom
Alder Hey Children's
Liverpool, L12 2AP, United Kingdom
King's College Hospital
London, SE5 9NY, United Kingdom
Great Ormond Street
London, WC1N 1EH, United Kingdom
Newcastle upon Tyne Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
University Hospital Southampton
Southampton, SO16 6YD, United Kingdom
Royal Manchester Children's Hospital
Victoria, 3052, United Kingdom
Related Publications (6)
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.
PMID: 29476389BACKGROUNDBell 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.
PMID: 29149394BACKGROUNDMiller 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.
PMID: 28430697BACKGROUNDLarsen 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.
PMID: 26627225BACKGROUNDAhmed N, Russo L, Kuo YH. Levetiracetam or Phenytoin as Prophylaxis for Status Epilepticus: Secondary Analysis of the "Approaches and Decisions in Acute Pediatric Traumatic Brain Injury Trial" (ADAPT) Dataset, 2014-2017. Pediatr Crit Care Med. 2024 Aug 1;25(8):710-719. doi: 10.1097/PCC.0000000000003526. Epub 2024 May 8.
PMID: 38717237DERIVEDSurtees TL, Kumar I, Garton HJL, Rivas-Rodriguez F, Parmar H, McCaffery H, Riebe-Rodgers J, Shellhaas RA. Levetiracetam Prophylaxis for Children Admitted With Traumatic Brain Injury. Pediatr Neurol. 2022 Jan;126:114-119. doi: 10.1016/j.pediatrneurol.2021.10.009. Epub 2021 Oct 19.
PMID: 34839268DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J Bell, MD
University of Pittsburgh Medical Center
- PRINCIPAL INVESTIGATOR
Stephen R Wisniewski, PhD
University of Pittsburgh
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 29, 2019
First Posted
September 4, 2019
Study Start
February 20, 2014
Primary Completion
September 26, 2016
Study Completion
August 28, 2018
Last Updated
December 8, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- One year after publication of main results paper.
- Access Criteria
- Investigators requesting and receiving FITBIR data are expected to: * Submit a Data Access Request; * Protect data confidentiality; * Ensure that data security measures are in place; * Notify the Data Access and Quality Committee of policy violations; * Submit annual progress reports detailing significant research findings; and * Include acknowledgements of the FITBIR Informatics System in all publications and presentations.
Study data will be released to the general public through FITBIR. ADAPT will adhere to all FITBIR policies and procedures.