The Ketogenic Diet for Pediatric Acute Brain Injury
Primary Purpose
Acute Brain Injuries
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ketogenic diet
Sponsored by
About this trial
This is an interventional other trial for Acute Brain Injuries focused on measuring Intensive Care Units, Pediatric
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:
- 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
Sites / Locations
- Ronald Reagan UCLA Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ketogenic diet
Arm Description
All subjects will be started on ketogenic diet formula feeding after enrollment for 2 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of episodes of low blood glucose levels
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.
Number of subjects with MRI brain spectroscopy peaks corresponding to ketone body compounds,
Number of subjects who develop kidney stones
Full Information
NCT ID
NCT02174016
First Posted
June 23, 2014
Last Updated
August 31, 2022
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT02174016
Brief Title
The Ketogenic Diet for Pediatric Acute Brain Injury
Official Title
The Ketogenic Diet for Pediatric Acute Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Suspended
Why Stopped
Funding
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Brain Injuries
Keywords
Intensive Care Units, Pediatric
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open label use of ketogenic diet in children with acute brain injury
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ketogenic diet
Arm Type
Experimental
Arm Description
All subjects will be started on ketogenic diet formula feeding after enrollment for 2 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketogenic diet
Primary Outcome Measure Information:
Title
Increase in Beta-hydroxybutyrate level
Description
Serum beta hydroxybutyrate levels will be checked daily, in order to determine how many days it will take to achieve elevated levels.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Number of episodes of low blood glucose levels
Time Frame
2 weeks
Title
Number of episodes of low serum bicarbonate levels
Description
Bicarbonate levels are expected to decrease because ketone bodies are acidic in nature, but episodes of excessively low bicarbonate levels will be assessed.
Time Frame
2 weeks
Title
Number of subjects with MRI brain spectroscopy peaks corresponding to ketone body compounds,
Time Frame
5 days
Title
Number of subjects who develop kidney stones
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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:
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
Facility Information:
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Ketogenic Diet for Pediatric Acute Brain Injury
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