Using a ketogenic diet for children with moderate to severe traumatic brain injury
Ketogenic Diet Following Moderate to Severe Pediatric Traumatic Brain Injury: A Pilot Study
This study is testing if a ketogenic diet can help children with moderate to severe traumatic brain injuries recover better than those who only get standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | Gillette Children's Specialty Healthcare Academic / other |
| Locations | 2 sites (Minneapolis, Minnesota and 1 other locations) |
| Trial ID | NCT04933448 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and safety of implementing a ketogenic diet (KD) in pediatric patients who have experienced moderate to severe traumatic brain injury (TBI). It aims to compare outcomes between children receiving standard care alone and those receiving standard care plus the KD. Key outcome measures include the need for surgical interventions, duration of unconsciousness, and cognitive and motor function at 12 months post-injury. If successful, this study will inform the design of a larger randomized trial to assess the efficacy of the KD in this population.
Who should consider this trial
Good fit: Ideal candidates are children aged 0-18 who have sustained moderate to severe traumatic brain injuries as defined by a Glasgow Coma Scale Score of 3-12.
Not a fit: Patients with non-accidental injuries, penetrating injuries, or significant anoxia/ischemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve recovery outcomes for children with traumatic brain injuries.
How similar studies have performed: While the ketogenic diet has shown success in treating refractory epilepsy, its application in traumatic brain injury is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age limits met at the time of injury and admission * Participants with moderate to severe traumatic brain injury defined as a Glasgow Coma Scale Score of 3-12 (lowest score in the first 24 hours after injury). Individuals requiring craniotomy and/or evacuation of intracranial hemorrhage may be included. Exclusion Criteria: * Currently on an oral diet at time of screening or currently on IV-only and in opinion of Pediatric Intensive Care Unit intensivist will be transitioning to an oral diet, not tube-feeding * Anoxia/ischemia as a significant portion of injury, including near-drowning * Non-accidental traumatic brain injury (i.e., assault, abuse) * Penetrating injury including gunshot wounds * Pregnancy * Any condition that in the opinion of the Pediatric Intensive Care Unit or neurosurgery medical staff warrants exclusion from the study
Where this trial is running
Minneapolis, Minnesota and 1 other locations
- Gillette Children's Specialty Healthcare — Minneapolis, Minnesota, United States (Recruiting)
- Children's Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Linda Krach, MD — Department of Physical Medicine and Rehabilitation
- Study coordinator: Linda Krach, MD
- Email: LKrach@gillettechildrens.com
- Phone: (651)-229-3873
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.