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NCT03055455 · ClinicalTrials.gov registry record
Neuroimaging and Neuromonitoring in Critically Ill Children With Sepsis
A clinical trial, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- 8
- Enrollment target
NCT03055455: Completed study, sponsored by Children's Hospital of Philadelphia.
NCT03055455 is a clinical trial that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 8 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03055455 has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- 8 participants
- Enrollment target
Study Summary
In critically ill children with severe sepsis, neurophysiologic derangements often proceed undetected and can lead to irreversible brain injury causing neurocognitive and behavioral deficits. The etiology of these impairments is unclear, however, it is likely that some of this neural injury is preventable. The overarching goal for this study is to show that acute acquired structural and microstructural brain injury occurs in critically ill children with severe sepsis, and that this injury is related to neuropsychological deficits and impaired cerebral autoregulation (CAR). Subjects will complete Magnetic resonance (MR) imaging within 2-10 days of recognition of their severe sepsis. Subjects will undergo serial interrogation of CAR for up to 10 days. CAR will be determined by the correlation of arterial blood pressure with middle cerebral artery flow velocity measured by transcranial doppler ultrasonography and cerebral oximetry derived from near-infrared spectroscopy. Subjects will also participate in a neuropsychological evaluation 6 months after enrollment to evaluate multiple domains of behavior and cognition.
Primary Outcome
Detection of signal abnormality on the patient's brain MRI scan.
Interventions
- DIAGNOSTIC_TEST MR imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2017-02-01 |
| Est. Completion | 2019-09-27 |
What the finished NCT03055455 record still lists
NCT03055455 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 8 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which MR imaging is the first listed.
NCT03055455 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03055455 about?
NCT03055455 is a clinical study titled "Neuroimaging and Neuromonitoring in Critically Ill Children With Sepsis". In critically ill children with severe sepsis, neurophysiologic derangements often proceed undetected and can lead to irreversible brain injury causing neurocognitive and behavioral deficits. The etiology of these impairments is unclear, however, it is likely that some of this neural injury is preve...
What is the current status of trial NCT03055455?
This trial is currently completed. The enrollment target is 8 participants. The study started on 2017-02-01. Estimated completion is 2019-09-27.
What interventions are being tested in trial NCT03055455?
The interventions under investigation include: MR imaging (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03055455?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
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