Actively Recruiting

Phase 1
Age: 0 - 6Months
All Genders
NCT06994949

Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus

Led by Eva Sevick · Updated on 2025-05-29

20

Participants Needed

1

Research Sites

207 weeks

Total Duration

On this page

Sponsors

E

Eva Sevick

Lead Sponsor

N

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus

Who Can Participate

Age: 0 - 6Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children born premature currently in the NICU with a diagnosis of PHH who have undergone ventricular reservoir placement.
  • For the first four study subjects, the child will attempt to undergo CT cisternography when clinically stable 3-4 weeks after reservoir placement.
Not Eligible

You will not qualify if you...

  • Parents who do not consent for procedure on their child.
  • Children deemed clinically unstable or unsuitable for imaging by clinical staff, including inability to be repositioned without compromising care.
  • Children known or suspected to have allergy to iodine or ICG.
  • Children without a subcutaneous reservoir for CSF diversion from the lateral ventricle.

AI-Screening

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Trial Site Locations

Total: 1 location

1

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

M

Manish Shah, MD

CONTACT

F

Fred C Velasquez

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus | DecenTrialz