Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus
Purpose
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.
Condition
- Post-hemorrhagic Hydrocephalus (PHH)
Eligibility
- Eligible Ages
-
Under 6 Months
- Eligible Genders
- All
- Accepts Healthy Volunteers
-
No
Inclusion Criteria
- 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.
Exclusion Criteria
- Parents who do not consent for procedure on their child
- Children who are deemed clinically unstable or unsuitable for imaging by clinical
staff as defined by the subject's level of intensive care (e.g. can the subject be
repositioned without compromise to the level of care needed or condition)
- Children known or suspected to have allergy to iodine or ICG
- Children who do not have a subcutaneous reservoir for CSF diversion from the lateral
ventricle
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
Experimental fCTOT and NIRF imaging with ICG
|
|
-
Device: 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.
-
Device: 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.
-
Drug: 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.
|
Recruiting Locations
The University of Texas Health Science Center at Houston
Houston,
Texas
77030
More Details
- Status
- Recruiting
- Sponsor
- Eva Sevick
Study Contact
Manish Shah, MD
(713) 500-7370
Manish.N.Shah@uth.tmc.edu