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Ketogenic Diet for Pediatric Traumatic Brain Injury

Q: What criteria must be fulfilled in order to partake of this medical research?

This clinical trial is seeking 21 young individuals with wounds, aged between 2 and 17. To qualify for enrollment, the patient must have met the age limit criteria at the time of admission. Furthermore, they need to display signs of moderate to severe <a href="https://www.withpower.com/clinical-trials/traumatic-brain-injury">traumatic brain injury</a> as indicated by a Glasgow Coma Scale Score from 3-12 (the initial score taken within 24 hours). Those requiring craniotomy or evacuation of intracranial haemorrhage can also take part in this research study.

Q: How many individuals are being enrolled in this investigation?

Affirmative. On clinicaltrials.gov, there is evidence that this clinical trial has opened recruitment for 21 individuals at two different medical centres. The original listing was on May 16th 2022 and the entry was last modified on August 2nd 2022.

Q: Could senior citizens aged 75 and above take part in this research?

In line with the terms of this clinical trial, minors between 2 and 17 are eligible to take part.

Q: Is there currently availablity for participants in this research?

Affirmative, the information on clinicaltrials.gov implies that recruitment is currently ongoing for this research project which was initially posted on May 16th 2022 and last updated on August 2nd 2022. The investigators require 21 volunteers to be sourced from two distinct medical centres.

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Ability to complete a course of the ketogenic diet (KD)

Secondary outcome measures

Duration of Acute Hospitalization

Duration of Post-traumatic Amnesia

Duration of Unconsciousness

+1 more

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).

Do I qualify?Apply below to find out

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

11,481 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must be fulfilled in order to partake of this medical research?

"This clinical trial is seeking 21 young individuals with wounds, aged between 2 and 17. To qualify for enrollment, the patient must have met the age limit criteria at the time of admission. Furthermore, they need to display signs of moderate to severe traumatic brain injury as indicated by a Glasgow Coma Scale Score from 3-12 (the initial score taken within 24 hours). Those requiring craniotomy or evacuation of intracranial haemorrhage can also take part in this research study."

Answered by AI

How many individuals are being enrolled in this investigation?

"Affirmative. On clinicaltrials.gov, there is evidence that this clinical trial has opened recruitment for 21 individuals at two different medical centres. The original listing was on May 16th 2022 and the entry was last modified on August 2nd 2022."

Answered by AI

Could senior citizens aged 75 and above take part in this research?

"In line with the terms of this clinical trial, minors between 2 and 17 are eligible to take part."

Answered by AI

Is there currently availablity for participants in this research?

"Affirmative, the information on clinicaltrials.gov implies that recruitment is currently ongoing for this research project which was initially posted on May 16th 2022 and last updated on August 2nd 2022. The investigators require 21 volunteers to be sourced from two distinct medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ketogenic Diet Following Moderate to Severe Pediatric Traumatic Brain Injury

2022. "Ketogenic Diet Following Moderate to Severe Pediatric Traumatic Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04933448.

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