Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus

Eva Sevick

Status and phase

Enrolling

Phase 1

Conditions

Post-hemorrhagic Hydrocephalus (PHH)

Treatments

Drug: ICG

Device: fCTOT cap

Device: NIRF planar imaging

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06994949

HSC-MS-21-0809

R01NS126437 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

Under 6 months old

Volunteers

No Healthy Volunteers

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