Status:
RECRUITING
Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus
Lead Sponsor:
Eva Sevick
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Post-hemorrhagic Hydrocephalus (PHH)
Eligibility:
All Genders
Up to 6 years
Phase:
PHASE1
Brief Summary
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 extracrania...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 3 2029
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06994949
Start Date
January 14 2025
End Date
January 3 2029
Last Update
May 29 2025
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030