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Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus
Sponsor: Eva Sevick
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.
Key Details
Gender
All
Age Range
Any - 6 Months
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-01-14
Completion Date
2029-01-03
Last Updated
2025-05-29
Healthy Volunteers
No
Conditions
Interventions
fCTOT cap
The fCTOT cap will be placed on the infant's head . After the MRI, fiber optics will be connected to the cap while donned on the infant and measurements will commence. After initial CSF diversion, a 0.5 cc volume of ICG solution will injected into the subcutaneous reservoir and measurements will be conducted using the fCTOT for 30 minutes. The fCTOT cap will be removed and NIRF planar imaging will be conducted to detect ICG in the subarachnoid space (SAS), draining cervical lymph nodes, along the spinal canal, and in the abdomen, where liver signals are expected. The infant will be transported back to the ICU where CSF diversion will continue and daily, 30 minutes NIRF imaging sessions may be conducted to detect ventricular flow into the SAS and liver clearance. Daily NIRF imaging will be performed in the neonatal intensive care unit (NICU) for as long as 7 days or until the ICG has cleared from the body from liver and/or CSF diversion.
NIRF planar imaging
The fCTOT cap will be placed on the infant's head . After the MRI, fiber optics will be connected to the cap while donned on the infant and measurements will commence. After initial CSF diversion, a 0.5 cc volume of ICG solution will injected into the subcutaneous reservoir and measurements will be conducted using the fCTOT for 30 minutes. The fCTOT cap will be removed and NIRF planar imaging will be conducted to detect ICG in the SAS, draining cervical lymph nodes, along the spinal canal, and in the abdomen, where liver signals are expected. The infant will be transported back to the ICU where CSF diversion will continue and daily, 30 minutes NIRF imaging sessions may be conducted to detect ventricular flow into the SAS and liver clearance. Daily NIRF imaging will be performed in the NICU for as long as 7 days or until the ICG has cleared from the body from liver and/or CSF diversion.
ICG
The fCTOT cap will be placed on the infant's head . After the MRI, fiber optics will be connected to the cap while donned on the infant and measurements will commence. After initial CSF diversion, a 0.5 cc volume of ICG solution will injected into the subcutaneous reservoir and measurements will be conducted using the fCTOT for 30 minutes. The fCTOT cap will be removed and NIRF planar imaging will be conducted to detect ICG in the SAS, draining cervical lymph nodes, along the spinal canal, and in the abdomen, where liver signals are expected. The infant will be transported back to the ICU where CSF diversion will continue and daily, 30 minutes NIRF imaging sessions may be conducted to detect ventricular flow into the SAS and liver clearance. Daily NIRF imaging will be performed in the NICU for as long as 7 days or until the ICG has cleared from the body from liver and/or CSF diversion.
Locations (1)
The University of Texas Health Science Center at Houston
Houston, Texas, United States