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NCT00715949 · ClinicalTrials.gov registry record
Neurocognitive Evaluation of Mild Traumatic Brain Injury in the Hospitalized Pediatric Population
A clinical trial, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- 120
- Enrollment target
NCT00715949: Completed study, sponsored by Children's Hospital of Philadelphia.
NCT00715949 is a clinical trial that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 120 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00715949 has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- 120 participants
- Enrollment target
Study 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.
Primary Outcome
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).
Interventions
- OTHER Immediate Post-concussion Assessment and Cognitive Testing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2005-12 |
| Est. Completion | 2014-06 |
What the finished NCT00715949 record still lists
NCT00715949 is an observational study that tracks outcomes without assigning an intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Immediate Post-concussion Assessment and Cognitive Testing is the first listed.
NCT00715949 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00715949 about?
NCT00715949 is a clinical study titled "Neurocognitive Evaluation of Mild Traumatic Brain Injury in the Hospitalized Pediatric Population". 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 ...
What is the current status of trial NCT00715949?
This trial is currently completed. The enrollment target is 120 participants. The study started on 2005-12. Estimated completion is 2014-06.
What interventions are being tested in trial NCT00715949?
The interventions under investigation include: Immediate Post-concussion Assessment and Cognitive Testing (OTHER).
Who is sponsoring clinical trial NCT00715949?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
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