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NCT04933448 · ClinicalTrials.gov registry record · NA
Ketogenic Diet Following Moderate to Severe Pediatric Traumatic Brain Injury
A NA study, sponsored by Gillette Children's Specialty Healthcare.
- Completed
- Registry status
- NA
- Development phase
- 7
- Enrollment target
NCT04933448: Completed NA study, sponsored by Gillette Children's Specialty Healthcare.
NCT04933448 is a NA study that has completed, run by Gillette Children's Specialty Healthcare. The registered enrollment target is 7 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04933448, a NA study, has completed, sponsored by Gillette Children's Specialty Healthcare.
- COMPLETED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
Study 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.
Primary Outcome
Safety and feasibility will be determined by the ability to complete a 14-day course of the KD after TBI without needing to terminate the diet due to intolerance resulting from gastrointestinal side effects (for example, nausea and vomiting, diarrhea, or acidosis), or due to abnormal findings on laboratory tests. Outcome is reported as the number of participants who complete the 14-day keto diet treatment.
Interventions
- OTHER Ketogenic Diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2022-05-16 |
| Est. Completion | 2024-12-31 |
| Phase | NA |
What the finished NCT04933448 record still lists
NCT04933448 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Ketogenic Diet is the first listed.
NCT04933448 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04933448 about?
NCT04933448 is a clinical study titled "Ketogenic Diet Following Moderate to Severe Pediatric Traumatic Brain Injury". 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 ...
What is the current status of trial NCT04933448?
This trial is currently completed. It is a NA study. The enrollment target is 7 participants. The study started on 2022-05-16. Estimated completion is 2024-12-31.
What interventions are being tested in trial NCT04933448?
The interventions under investigation include: Ketogenic Diet (OTHER).
Who is sponsoring clinical trial NCT04933448?
This trial is sponsored by Gillette Children's Specialty Healthcare, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04933448's enrollment target sits among peer trials
7 1982nd of 2000 higher than 18 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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