Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus

Phase 1

Recruiting

• Conditions: Post-hemorrhagic Hydrocephalus (PHH)
• Interventions: Device: fCTOT cap; Device: NIRF planar imaging; Drug: ICG

• Registration Number: NCT06994949
• Lead Sponsor: Eva Sevick

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-14
• Status Verified: 2025-05
• Study First Submitted: 2025-05-20
• Study First Submitted QC: 2025-05-20
• Last Update Submitted: 2025-05-20
• Study First Posted: 2025-05-29
• Last Update Posted: 2025-05-29
• Primary Completion: 2029-01-03
• Study Completion: 2029-01-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fCTOT and NIRF imaging with ICG	fCTOT cap	-
fCTOT and NIRF imaging with ICG	NIRF planar imaging	-
fCTOT and NIRF imaging with ICG	ICG	-

Primary Outcome Measures

Name	Time	Method
Number of participants 1-2 months of age who present with elevated ventriculomegaly after Endoscopic Third Ventriculostomy (ETV)/Choroid Plexus Cauterization (CPC) as assessed by the clinical MRI examination	end of study (about 10 days form baseline)
Number of participants 1-6 months of age who present with continuing ventriculomegaly after ETV/CPC as assessed by the clinical MRI examination	end of study (about 10 days form baseline)
Number of participants 1-2 weeks of age who present with continuing ventriculomegaly after CSF diversion as assessed by the clinical MRI examination	end of study (about 10 days form baseline)

Secondary Outcome Measures

Name	Time	Method
Amount of pro-inflammatory cytokines measured in pg/ml	end of study (about 10 days form baseline)	Cytokines include Interleukin (IL)-1beta IL-4 IL-6 IL-10 IFNgamma TNFalpha Neural Cell Adhesion Molecule 1 (NCAM-1) Monocyte chemoattractant protein-1(MCP-1) IL-18

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States