Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The purpose of this study is to evaluate the safety and efficacy of ventricular microdosing of indocyanine green (ICG) in order to assess cerebrospinal fluid (CSF) ventricular dynamics and extracranial CSF outflow using fluorescent Cap-based Transcranial Optical Tomography (fCTOT) and Near-InfraRed Fluorescent (NIRF) imaging and to evaluate inflammation markers of the CSF and to correlate with CSF ventricular dynamics, extracranial outflow into the lymphatics, ventriculomegaly, and patient's clinical outcome in order to understand how inflammation may impact that status of extracranial outflow.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 6 months
Healthy Volunteers: f
View:

• Children born premature currently in the NICU with a diagnosis of PHH who have undergone ventricular reservoir placement.

• For the first four study subjects, we will attempt for the child to undergo CT cisternography when clinically stable 3-4 weeks after reservoir placement.

Locations
United States
Texas
The University of Texas Health Science Center at Houston
RECRUITING
Houston
Contact Information
Primary
Manish Shah, MD
Manish.N.Shah@uth.tmc.edu
(713) 500-7370
Backup
Fred C Velasquez
Fred.Christian.Velasquez@uth.tmc.edu
713-500-3645
Time Frame
Start Date: 2025-01-14
Estimated Completion Date: 2029-01-03
Participants
Target number of participants: 20
Treatments
Experimental: fCTOT and NIRF imaging with ICG
Related Therapeutic Areas
Sponsors
Leads: Eva Sevick
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov