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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Children's Hospital of Philadelphia.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
University of Pittsburgh
University of Pennsylvania
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00715949
First received: July 14, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  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
Other: ImPACT

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:
  • To assess the feasibility of inpatient bedside neurocognitive testing of pediatric patients with minor traumatic brain injury. [ Time Frame: study completion ] [ Designated as safety issue: No ]

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: 116
Study Start Date: December 2005
Estimated Study Completion Date: December 2009
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
admitted pediatric patients with minor traumatic brain injury
Other: ImPACT
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 minor 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, minor traumatic brain injury will include patients with a 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: Michael L. Nance, MD, 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
Last Updated: July 14, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 28, 2014