Ketogenic Diet Following Moderate to Severe Pediatric Traumatic Brain Injury

Completed · Not applicable

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT04933448

Run by

Gillette Children's Specialty Healthcare

People needed

7

Starts

2022-05-16

Expected to finish

2024-12-31

Last updated by the study team

2026-02-12

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Children's Minnesota — Minneapolis, Minnesota, United States
• Gillette Children's Specialty Healthcare — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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