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

NCT00715949 | Completed Results

• 1 other identifier: 2005-11-4572
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Traumatic Brain Injury; Concussion

Keywords

traumatic brain injury; pediatric; neurocognitive; concussion

Outcome Measures

Primary Outcomes (1)

• The Feasibility of Inpatient Bedside Neurocognitive Testing of Pediatric Patients With Minor Traumatic Brain Injury.

  In this study, we demonstrated the feasibility of administering a previously validated, computer-based neurocognitive test battery in the inpatient setting. Participation numbers were determined by the ability of the participant to attend to and complete computerized neurocognitive testing while hospitalized with minor traumatic brain injury (MTBI).

  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.

Secondary Outcomes (1)

• To Establish if Neurocognitive Deficits Exist, and to What Extent, in the Cohort of Hospitalized Pediatric Patients With Minor Traumatic Brain Injury.

  study completion

Study Arms (1)

Mild Traumatic Brain Injury (MTBI) admits

admitted pediatric patients with mild traumatic brain injury (concussion)

Other: Immediate Post-concussion Assessment and Cognitive Testing

Interventions

Immediate Post-concussion Assessment and Cognitive Testing OTHER

ImPACT© utilizes a battery of neurocognitive tests to assess neurologic deficits.

Mild Traumatic Brain Injury (MTBI) admits

Eligibility Criteria

• Age: 11 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patients with penetrating injuries as well as patients treated and released from the emergency room will be excluded.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• University of Pittsburgh: collaborator
• University of Pennsylvania: collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Nance ML, Polk-Williams A, Collins MW, Wiebe DJ. Neurocognitive evaluation of mild traumatic brain injury in the hospitalized pediatric population. Ann Surg. 2009 May;249(5):859-63. doi: 10.1097/SLA.0b013e3181a41ae5.

  PMID: 19387313 DERIVED

MeSH Terms

Conditions

Brain Concussion; Brain Injuries, Traumatic

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Michael L. Nance
• Organization: The Children's Hospital of Philadelphia

nance@email.chop.edu

215-590-5932

Study Officials

• Michael L. Nance, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2008
• First Posted: July 15, 2008
• Study Start: December 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: June 1, 2014
• Last Updated: May 4, 2015
• Results First Posted: October 15, 2014

Record last verified: 2015-04

Locations

US (1)