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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 is a NA study that has completed, run by Gillette Children's Specialty Healthcare. The registered enrollment target is 7 participants.
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.
Interventions
- OTHER Ketogenic Diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2022-05-16 |
| Est. Completion | 2024-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04933448
The ClinicalTrials.gov registry entry for NCT04933448 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gillette Children's Specialty Healthcare, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ketogenic Diet is the first listed.
NCT04933448 reports 0 study locations.
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.
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