Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus

ConditionPost-hemorrhagic Hydrocephalus (PHH)

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

AgeUp to 6

SponsorEva Sevick

About this trial

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

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

fCTOT cap
NIRF planar imaging
ICG

Treatment groups

20 Participants

are divided into 1 treatment group

Sponsors and collaborators

Eva Sevick

Lead sponsor

The University of Texas Health Science Center, Houston

Sponsor institution

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Source ClinicalTrials.gov