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Ketogenic Diet for Pediatric Traumatic Brain Injury

N/A
Recruiting
Led By Angela Sinner, DO
Research Sponsored by Gillette Children's Specialty Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether the ketogenic diet is safe and feasible to use in children who have sustained moderate to severe traumatic brain injury, as well as whether it leads to better outcomes than the standard of care alone.

Who is the study for?
This trial is for children with moderate to severe traumatic brain injury, defined by a Glasgow Coma Scale Score of 3-12. It's open to those who are not on an oral diet and don't have conditions that would exclude them as per medical staff judgment. Children with non-accidental injuries or significant oxygen deprivation from near-drowning aren't eligible.
What is being tested?
The study tests the safety and feasibility of a ketogenic diet in addition to standard care for pediatric TBI compared to standard care alone. Outcomes like recovery time, cognitive function, and hospital stay length will be measured to plan future larger trials.
What are the potential side effects?
While specific side effects are not listed, the ketogenic diet can typically cause digestive issues, changes in blood sugar levels, potential nutrient deficiencies, and may affect growth patterns in children.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ability to complete a course of the ketogenic diet (KD)
Secondary study objectives
Duration of Acute Hospitalization
Duration of Post-traumatic Amnesia
Duration of Unconsciousness
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Prospective Intervention GroupExperimental Treatment1 Intervention
Participants will receive standard of care for acute management of moderate to severe traumatic brain injury, together with a weight-based ketogenic diet added for up to fourteen days.
Group II: Historical Control GroupActive Control1 Intervention
Medical records of past TBI patients will be used as controls matched for age, gender, socioeconomic status (type of health care coverage including private insurance vs. government-funded coverage), lowest first 24 hour post-injury Glasgow Coma Score (GCS) (\<8 or 8-12), and pre-injury school program (regular or special education).

Find a Location

Who is running the clinical trial?

State of Minnesota Spinal Cord Injury and Traumatic Brain Injury Research Grant ProgramUNKNOWN
Gillette Children's Specialty HealthcareLead Sponsor
30 Previous Clinical Trials
8,050 Total Patients Enrolled
Children's MinnesotaUNKNOWN

Media Library

Ketogenic Diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04933448 — N/A
Traumatic Brain Injury Research Study Groups: Historical Control Group, Prospective Intervention Group
Traumatic Brain Injury Clinical Trial 2023: Ketogenic Diet Highlights & Side Effects. Trial Name: NCT04933448 — N/A
Ketogenic Diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04933448 — N/A
~6 spots leftby Nov 2025
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