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Tracking Brain Fluid Flow With a Glowing Dye in Infants With Hydrocephalus After Bleeding

Tests a glowing dye to trace brain fluid flow in infants with post-hemorrhagic hydrocephalus.

Key facts

Who runs it
Eva Sevick
Where
Houston, United StatesSee the site
Trial code
Registry title
Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus
Status
Recruiting
Phase
Phase 1
People taking part
20 people, planned
Started
14 Jan 2025
Expected to end
3 Jan 2029
Type of study
Interventional
Treatments tested
  • fCTOT cap
  • NIRF planar imaging
  • ICG
Record updated
29 May 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for babies born early who are in the newborn intensive care unit (NICU) with hydrocephalus after bleeding in the brain (PHH). They must already have a ventricular reservoir, a small device under the skin that drains brain fluid.

Age
Up to 6 Months
Sex
All
Disease stage
Post-hemorrhagic hydrocephalus (PHH) in babies born premature who are currently in the NICU.
Earlier treatment
Must have had a ventricular reservoir placed under the skin to drain fluid from the lateral ventricle of the brain.

Main reasons for not taking part

  • Parents do not agree to the procedure for their child
  • Child is too unstable for imaging, as judged by the care team
  • Known or suspected allergy to iodine or ICG
  • No reservoir under the skin to drain brain fluid from the lateral ventricle

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Parents who do not consent for procedure on their child
  • Children who do not have a subcutaneous reservoir for CSF diversion from the lateral ventricle

Where in United States

  • The University of Texas Health Science Center at HoustonHouston, United StatesContact: Manish Shah, MDTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • fCTOT and NIRF imaging with ICGTreatment being tested

    Treatment: fCTOT cap, NIRF planar imaging, and ICG

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus
Plain-language title
Tracking Brain Fluid Flow With a Glowing Dye in Infants With Hydrocephalus After BleedingGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
29 May 2025