The Ketogenic Diet for Pediatric Acute Brain Injury
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 1 - 17 |
| Updated: | 2/17/2018 |
| Start Date: | January 2015 |
| End Date: | December 2020 |
| Contact: | Joyce H Matsumoto, MD |
| Phone: | 310-825-6196 |
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.
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.
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:
1. True milk allergy (anaphylaxis or severe rash)
2. Significant gastrointestinal injury precluding enteral feeding
3. Hepatic or renal insufficiency
4. History of nephrolithiasis
5. Severe acidosis (serum bicarbonate ≤ 17 mEq/L) resistant to correction
6. History of inborn error of metabolism
7. Preexisting epilepsy or developmental delay
We found this trial at
1
site
Los Angeles, California 90095
Principal Investigator: Joyce H Matsumoto, MD
Phone: 310-825-6196
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