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N/A N=120

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

Mild Traumatic Brain Injury · Concussion

Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: The Feasibility of Inpatient Bedside Neurocognitive Testing of Pediatric Patients With Minor Traumatic Brain Injury. — 120 participants

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Immediate Post-concussion Assessment and Cognitive Testing (Other)
Age
Pediatric, Adult · 11+ yrs
Sex
All
Sponsor
Children's Hospital of Philadelphia
Primary completion
Dec 2007

Outcome Measures

OutcomeResultp-value
PRIMARY
The Feasibility of Inpatient Bedside Neurocognitive Testing of Pediatric Patients With Minor Traumatic Brain Injury.
120
SECONDARY
To Establish if Neurocognitive Deficits Exist, and to What Extent, in the Cohort of Hospitalized Pediatric Patients With Minor Traumatic Brain Injury.

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.

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00715949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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