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Neurocognitive Evaluation of Mild Traumatic Brain Injury in the Hospitalized Pediatric Population

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Pittsburgh
University of Pennsylvania
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00715949
First received: July 14, 2008
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

Brain injuries from trauma are common in children, often resulting in death and disability. Most brain injuries are minor, yet their treatment can be challenging. Because there are many different scales used to characterize the severity of brain injury, there is no consensus regarding how to manage patients with minor brain injuries. Specifically, there is no agreement on recommendations regarding the safety of return to activities following injury. In young athletes with minor brain injuries (i.e. concussions) there is strong data suggesting that return to baseline neurologic function is often delayed by days or weeks. Children allowed to return to activities too soon may be at a higher risk for a second concussion, may delay recovery or, in rare cases, die. Researchers have designed a computer-based testing system (ImPACT©) to objectively test for neurologic deficits following injury. This test has been used primarily in athletes following a concussion but is also applicable to children with brain injuries from non-sports related traumas. We propose to utilize this testing in pediatric patients admitted to the hospital with minor brain injury. The test would be administered at the time of the hospitalization as well as in the outpatient trauma clinic at the time of routine follow up. The test would allow us to determine if there are neurologic deficits, potentially subclinical, in these brain injured patients and how quickly they recover from their injuries. If successful, the testing will likely be useful in other clinical settings such as the primary care office (e.g. pediatrician), specialty care office (e.g. sports medicine), or emergency room to determine if an injured child requires additional intervention.


Condition Intervention
Mild Traumatic Brain Injury
Concussion
Other: Immediate Post-concussion Assessment and Cognitive Testing

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Neurocognitive Evaluation of Minor Traumatic Brain Injury in the Hospitalized Pediatric Population

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • The Feasibility of Inpatient Bedside Neurocognitive Testing of Pediatric Patients With Minor Traumatic Brain Injury. [ Time Frame: Initial testing within 72 hours of injury and subsequent testing at approximately 2-3 weeks after injury. Subjects were offered the opportunity to also undergo testing at 3 months post-injury. ] [ Designated as safety issue: No ]
    In this study, we demonstrated the feasibility of administering a previously validated, computer-based neurocognitive test battery in the inpatient setting. Feasibility was determined by the ability of the participant to attend to and complete computerized neurocognitive testing while hospitalized with MTBI.


Secondary Outcome Measures:
  • To Establish if Neurocognitive Deficits Exist, and to What Extent, in the Cohort of Hospitalized Pediatric Patients With Minor Traumatic Brain Injury. [ Time Frame: study completion ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: December 2005
Estimated Study Completion Date: June 2016
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Mild Traumatic Brain Injury (MTBI) admits
admitted pediatric patients with mild traumatic brain injury (concussion)
Other: Immediate Post-concussion Assessment and Cognitive Testing
ImPACT© utilizes a battery of neurocognitive tests to assess neurologic deficits.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   11 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric blunt trauma patients (age 11-19 years) admitted to The Children's Hospital of Philadelphia for treatment of mild traumatic brain injury

Criteria

Inclusion Criteria:

  • Pediatric blunt trauma patients (age 11-19 years) admitted for treatment of minor traumatic brain injury will be eligible for inclusion in the study. For the purposes of this study, mild traumatic brain injury will include patients with a Glasgow Coma Scale (GCS) of 14-15 upon arrival in the trauma receiving area. This may include those patients with and without abnormalities on head CT scans.
  • Children will be included regardless of race, gender or ethnicity. The distribution of gender, race, and ethnicity is expected to reflect that of the trauma population at The Children's Hospital of Philadelphia

Exclusion Criteria:

  • Patients with penetrating injuries as well as patients treated and released from the emergency room will be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715949

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
University of Pittsburgh
University of Pennsylvania
Investigators
Principal Investigator: Michael L. Nance, MD Children's Hospital of Philadelphia
  More Information

No publications provided by Children's Hospital of Philadelphia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00715949     History of Changes
Other Study ID Numbers: 2005-11-4572
Study First Received: July 14, 2008
Results First Received: July 29, 2013
Last Updated: October 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
traumatic brain injury
pediatric
neurocognitive
concussion

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014