Clinical trial NCT04933448: Ketogenic Diet Following Moderate to Severe Pediatric Traumatic Brain Injury
Official title: Ketogenic Diet Following Moderate to Severe Pediatric Traumatic Brain Injury: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: Gillette Children's Specialty Healthcare
Sponsor class: OTHER
Collaborators: name: State of Minnesota Spinal Cord Injury and Traumatic Brain Injury Research Grant Program
name: Children's Minnesota
First posted: 2021-06-21
Enrollment: 21
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the feasibility and safety of using the ketogenic diet (KD) in children who sustained moderate to severe traumatic brain injury (TBI). The secondary objective is a preliminary evaluation of the outcomes of children who have had the standard of care plus the KD, compared to those with standard of care alone. Outcome measures for the secondary objective will include: need for ventriculoperitoneal shunt, duration of unconsciousness, need for any type of craniotomy, duration of post-traumatic amnesia, acute hospitalization length of stay, and cognitive and motor function at 12 months after injury. If this study demonstrates feasibility and safety, the information related to outcomes will be used to inform the planning of a future, larger, randomized study of the efficacy of the KD in children and adolescents with TBI. Specifically, this information will be used to assist with sample size calculations for this future study.

Detailed description: The KD is an alternative feeding regimen that has been in use since 1921. It is a high fat, low carbohydrate and moderate protein diet. There are various forms of the KD. The classic KD consists of long-chain triglycerides with a fat-to-combined-protein-and-carbohydrate ratio that can vary. At our institution, it is standard of care to initiate a ketogenic diet at a ratio of 2:1, and to increase the ratio to 3:1 or 4:1 as needed to achieve ketosis. Clinically, the KD has been proven to be an effective therapy in children and adolescents with refractory epilepsy, as well as for those with type II diabetes. In addition, an international consensus was published in 2009 that recommended the use of the KD to treat epilepsy refractory as an alternative to at least two antiepileptic medications. Before initiating the KD for epilepsy management, labs such as urine and blood ketones, blood glucose and a basic metabolic panel including magnesium are commonly recommended. Risks for long-term use of the KD include but are not limited to the following: hypercholesterolemia, mineral deficiencies, acidosis, constipation, weight loss and nephrolithiasis. However, short-term use should significantly limit the occurrence of these potential complications.

Eligibility 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

Primary outcomes:
measure: Ability to complete a course of the ketogenic diet (KD)
timeFrame: 14 days
Secondary outcomes:
measure: Duration of Unconsciousness
timeFrame: 14 days
measure: Need for Surgeries
timeFrame: 14 days
measure: Duration of Acute Hospitalization
timeFrame: 14 days
measure: Duration of Post-traumatic Amnesia
timeFrame: 14 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Gillette Children's Specialty Healthcare
state: Minnesota
city: Minneapolis
country: United States
facility: Children's Minnesota
state: Minnesota
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation
name: Linda Krach, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Physical Medicine and Rehabilitation
name: Angela Sinner, DO
role: PRINCIPAL_INVESTIGATOR
References: