Clinical Trials Directory

Trials / Completed

CompletedNCT03055455

Neuroimaging and Neuromonitoring in Critically Ill Children With Sepsis

Status
Completed
Phase
Study type
Observational
Enrollment
8 (actual)
Sponsor
Children's Hospital of Philadelphia · Academic / Other
Sex
All
Age
3 Years – 18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTMR imagingConventional structural imaging will be combined with advanced neuroimaging modalities to evaluate integrity of white matter tracts, regional brain perfusion, and the 3-dimensional volume of specific brain structures.

Timeline

Start date
2017-02-01
Primary completion
2019-09-27
Completion
2019-09-27
First posted
2017-02-16
Last updated
2021-04-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03055455. Inclusion in this directory is not an endorsement.