Neurocognitive Evaluation of Mild Traumatic Brain Injury in the Hospitalized Pediatric Population
Recruitment status was Active, not recruiting
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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 |
- 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 ]
- 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 |
Pediatric blunt trauma patients (age 11-19 years) admitted to The Children's Hospital of Philadelphia for treatment of minor traumatic brain injury
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| United States, Pennsylvania | |
| The Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| 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 Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013