Ketogenic Diet Following Moderate to Severe Pediatric Traumatic Brain Injury

NCT ID: NCT04933448

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-16
• Study Completion Date: 2025-09-30

Brief Summary

The primary objective of this study is to evaluate the feasibility and safety of using the ketogenic diet (KD) in children who sustained moderate to severe traumatic brain injury (TBI). The secondary objective is a preliminary evaluation of the outcomes of children who have had the standard of care plus the KD, compared to those with standard of care alone. Outcome measures for the secondary objective will include: need for ventriculoperitoneal shunt, duration of unconsciousness, need for any type of craniotomy, duration of post-traumatic amnesia, acute hospitalization length of stay, and cognitive and motor function at 12 months after injury. If this study demonstrates feasibility and safety, the information related to outcomes will be used to inform the planning of a future, larger, randomized study of the efficacy of the KD in children and adolescents with TBI. Specifically, this information will be used to assist with sample size calculations for this future study.

Detailed Description

The KD is an alternative feeding regimen that has been in use since 1921. It is a high fat, low carbohydrate and moderate protein diet. There are various forms of the KD. The classic KD consists of long-chain triglycerides with a fat-to-combined-protein-and-carbohydrate ratio that can vary. At our institution, it is standard of care to initiate a ketogenic diet at a ratio of 2:1, and to increase the ratio to 3:1 or 4:1 as needed to achieve ketosis. Clinically, the KD has been proven to be an effective therapy in children and adolescents with refractory epilepsy, as well as for those with type II diabetes. In addition, an international consensus was published in 2009 that recommended the use of the KD to treat epilepsy refractory as an alternative to at least two antiepileptic medications. Before initiating the KD for epilepsy management, labs such as urine and blood ketones, blood glucose and a basic metabolic panel including magnesium are commonly recommended. Risks for long-term use of the KD include but are not limited to the following: hypercholesterolemia, mineral deficiencies, acidosis, constipation, weight loss and nephrolithiasis. However, short-term use should significantly limit the occurrence of these potential complications.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Prospective Intervention Group

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 Type: EXPERIMENTAL

Ketogenic Diet

Intervention Type: OTHER

The ketogenic diet (KD) is an alternative feeding regimen that has been in use since 1921. It is a high-fat, low carbohydrate, and moderate protein diet. There are various forms of the KD. The classic KD consists of long-chain triglycerides with a fat-to-combined-protein-and-carbohydrate ratio that can vary. At the investigating institution, it is standard of care to initiate a ketogenic diet at a ratio of 2:1, and to increase the ratio to 3:1 or 4:1 as needed to achieve ketosis.

Historical Control Group

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ketogenic Diet

The ketogenic diet (KD) is an alternative feeding regimen that has been in use since 1921. It is a high-fat, low carbohydrate, and moderate protein diet. There are various forms of the KD. The classic KD consists of long-chain triglycerides with a fat-to-combined-protein-and-carbohydrate ratio that can vary. At the investigating institution, it is standard of care to initiate a ketogenic diet at a ratio of 2:1, and to increase the ratio to 3:1 or 4:1 as needed to achieve ketosis.

Intervention Type: OTHER

Other Intervention Names

Keto

Eligibility Criteria

Inclusion Criteria

• Age limits met at the time of injury and admission
• Participants with moderate to severe traumatic brain injury defined as a Glasgow Coma Scale Score of 3-12 (lowest score in the first 24 hours after injury). Individuals requiring craniotomy and/or evacuation of intracranial hemorrhage may be included.

Exclusion Criteria

• Currently on an oral diet at time of screening or currently on IV-only and in opinion of Pediatric Intensive Care Unit intensivist will be transitioning to an oral diet, not tube-feeding
• Anoxia/ischemia as a significant portion of injury, including near-drowning
• Non-accidental traumatic brain injury (i.e., assault, abuse)
• Penetrating injury including gunshot wounds
• Pregnancy
• Any condition that in the opinion of the Pediatric Intensive Care Unit or neurosurgery medical staff warrants exclusion from the study

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State of Minnesota Spinal Cord Injury and Traumatic Brain Injury Research Grant Program

UNKNOWN

Sponsor Role: collaborator

Children's Minnesota

UNKNOWN

Sponsor Role: collaborator

Gillette Children's Specialty Healthcare

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linda Krach, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Medicine and Rehabilitation

Angela Sinner, DO

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Medicine and Rehabilitation

Locations

Gillette Children's Specialty Healthcare

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Children's Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Linda Krach, MD

Role: CONTACT

LKrach@gillettechildrens.com

(651)-229-3873

Angela Sinner, DO

Role: CONTACT

ASinner@gillettechildrens.com

(651)-325-2317

Facility Contacts

Linda Krach, MD

Role: primary

LKrach@gillettechildrens.com

651-229-3873

Andrew Kiragu, MD

Role: primary

Andrew.Kiragu@childrensmn.org

Other Identifiers

STUDY00009115

Identifier Type: -

Identifier Source: org_study_id