Home › Premature Birth › NCT06994949

Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus

Who can join

6 Months · All sexes

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

About the study

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.

What is being tested

• fCTOT cap (device)
• NIRF planar imaging (device)
• ICG (drug)

Sponsor: Eva Sevick · Participants: 20 · Started: Jan 14, 2025

Contact the study team

• Manish Shah, MD · Phone: (713) 500-7370
• Fred C Velasquez · Phone: 713-500-3645

Official record on ClinicalTrials.gov — NCT06994949

Locations in the U.S.

Conditions

• Premature Birth

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.