Clinical trial NCT02174016: The Ketogenic Diet for Pediatric Acute Brain Injury
Official title: The Ketogenic Diet for Pediatric Acute Brain Injury
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Acute Brain Injuries
Keywords: Intensive Care Units
Pediatric
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 5
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label use of ketogenic diet in children with acute brain injury
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Increase in Beta-hydroxybutyrate level
timeFrame: 2 weeks
Secondary outcomes:
measure: Number of episodes of low blood glucose levels
timeFrame: 2 weeks
measure: Number of episodes of low serum bicarbonate levels
timeFrame: 2 weeks
measure: Number of subjects with MRI brain spectroscopy peaks corresponding to ketone body compounds,
timeFrame: 5 days
measure: Number of subjects who develop kidney stones
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
Study officials:
References: