NCT06994949PHASE1Recruiting
Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus
Eva Sevick
Start Date
1/14/2025
Completion Date
1/3/2029
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 Criteria
Age Range: No minimum to No maximum
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
Interventions
DEVICE
fCTOT cap
DEVICE
NIRF planar imaging
DRUG
ICG
Conditions
Post-hemorrhagic Hydrocephalus (PHH)
Locations
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United States