Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus
Recruiting now · Phase 1
Conditions studied: Post-hemorrhagic Hydrocephalus (PHH)
In brief
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.
Key facts
- Study ID
- NCT06994949
- Run by
- Eva Sevick
- People needed
- 20
- Starts
- 2025-01-14
- Expected to finish
- 2029-01-03
- Last updated by the study team
- 2025-05-29
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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