Trial Outcomes & Findings for Neurocognitive Evaluation of Mild Traumatic Brain Injury in the Hospitalized Pediatric Population (NCT NCT00715949)

NCT ID: NCT00715949

Last Updated: 2015-05-04

Results Overview

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).

• Recruitment status: COMPLETED
• Target enrollment: 120 participants
• Primary outcome timeframe: 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.
• Results posted on: 2015-05-04

Participant Flow

Participant milestones

Measure	Admitted Pediatric With MTBI admitted pediatric patients with minor traumatic brain injury participating in computerized neurocognitive testing
Overall Study STARTED	120
Overall Study COMPLETED	116
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Admitted Pediatric With MTBI admitted pediatric patients with minor traumatic brain injury participating in computerized neurocognitive testing
Overall Study could not finish first test	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Admitted Pediatric With MTBI n=116 Participants admitted pediatric patients with minor traumatic brain injury
Age, Categorical <=18 years	116 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	14.1 years STANDARD_DEVIATION 1.8 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	81 Participants n=5 Participants
Region of Enrollment United States	116 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Population: Analysis population includes only subjects who completed computerized neurocognitive tests. 120 subjects began the study, however 4 dropped out because they were unable to complete the first test and were not included in the final number of analyzed participants.

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).

Outcome measures

Measure	Admitted Pediatric With MTBI n=120 Participants admitted pediatric patients with minor traumatic brain injury
The Feasibility of Inpatient Bedside Neurocognitive Testing of Pediatric Patients With Minor Traumatic Brain Injury.	120 participants

SECONDARY outcome

Timeframe: study completion

Outcome measures

Outcome data not reported

Adverse Events

Admitted Pediatric With MTBI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael L. Nance

The Children's Hospital of Philadelphia

Phone: 215-590-5932

Email: nance@email.chop.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place