The Ketogenic Diet for Pediatric Acute Brain Injury

Study Overview
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Brief Summary
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This is a prospective pilot study evaluating the safety and feasibility of implementing the ketogenic diet in children admitted to the pediatric intensive care unit with acute brain injury such as stroke, traumatic brain injury, and intracerebral hemorrhage. Animal studies suggest that in the aftermath of injury the brain's ability to use glucose as a fuel is impaired. The ketogenic diet is a high fat, low carbohydrate diet which is already used in clinical practice for the treatment of medication resistant epilepsy and is intended to switch the body over to burning fat rather than carbohydrates for fuel. In lieu of their standard tube-feeds, 5-10 children admitted to the PICU with these diagnoses will receive low carbohydrate, high fat ketogenic feeds for 2 weeks. We hypothesize that ketones will be detectable through serum tests and MRI spectroscopy studies of the brain within several days of diet initiation, and that there will be a low incidence of side effects and adverse events, Measures of interest will include the incidence of kidney stones, excessive acidosis and excessive hypoglycemia. The feasibility of implementing this protocol for a larger efficacy trial will be assessed through serial measurements of blood glucose, beta-hydroxybutyrate (a type of ketone body), and serum bicarbonate levels. In addition, levels of ketone bodies within the brain will be measured through MRI spectroscopy sequence which will be acquired at the same time as a follow-up MRI brain study ordered for clinical purposes.

Official Title
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The Ketogenic Diet for Pediatric Acute Brain Injury

Conditions
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Acute Brain Injuries

Intervention / Treatment
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* Dietary Supplement: Ketogenic diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children age -17 years admitted to the pediatric intensive care unit with acute brain injury such as acute stroke, severe traumatic brain injury, and intracerebral hemorrhage Exclusion Criteria: True milk allergy (anaphylaxis or severe rash) Significant gastrointestinal injury precluding enteral feeding Hepatic or renal insufficiency History of nephrolithiasis Severe acidosis (serum bicarbonate ≤ 17 mEq/L) resistant to correction History of inborn error of metabolism Preexisting epilepsy or developmental delay

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Open label use of ketogenic diet in children with acute brain injury
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketogenic diet<br>All subjects will be started on ketogenic diet formula feeding after enrollment for 2 weeks. | Dietary Supplement: Ketogenic diet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in Beta-hydroxybutyrate level | Serum beta hydroxybutyrate levels will be checked daily, in order to determine how many days it will take to achieve elevated levels. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of episodes of low blood glucose levels |  | 2 weeks | 
| Number of episodes of low serum bicarbonate levels | Bicarbonate levels are expected to decrease because ketone bodies are acidic in nature, but episodes of excessively low bicarbonate levels will be assessed. | 2 weeks | 
| Number of subjects with MRI brain spectroscopy peaks corresponding to ketone body compounds, |  | 5 days | 
| Number of subjects who develop kidney stones |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive Care Units, Pediatric