Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus

NCT06994949 | Recruiting Phase 1 DMC FDA Drug FDA Device

• 2 other identifiers: HSC-MS-21-0809R01NS126437
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-hemorrhagic Hydrocephalus (PHH)

Keywords

cerebrospinal fluid (CSF); premature infants; indocyanine green (ICG)

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

Secondary Outcomes (1)

• Amount of pro-inflammatory cytokines measured in pg/ml

  end of study (about 10 days form baseline)

Study Arms (1)

fCTOT and NIRF imaging with ICG

EXPERIMENTAL

Device: fCTOT cap; Device: NIRF planar imaging; Drug: ICG

Interventions

fCTOT cap DEVICE

The fCTOT cap will be placed on the infant's head . After the MRI, fiber optics will be connected to the cap while donned on the infant and measurements will commence. After initial CSF diversion, a 0.5 cc volume of ICG solution will injected into the subcutaneous reservoir and measurements will be conducted using the fCTOT for 30 minutes. The fCTOT cap will be removed and NIRF planar imaging will be conducted to detect ICG in the subarachnoid space (SAS), draining cervical lymph nodes, along the spinal canal, and in the abdomen, where liver signals are expected. The infant will be transported back to the ICU where CSF diversion will continue and daily, 30 minutes NIRF imaging sessions may be conducted to detect ventricular flow into the SAS and liver clearance. Daily NIRF imaging will be performed in the neonatal intensive care unit (NICU) for as long as 7 days or until the ICG has cleared from the body from liver and/or CSF diversion.

fCTOT and NIRF imaging with ICG

NIRF planar imaging DEVICE

The fCTOT cap will be placed on the infant's head . After the MRI, fiber optics will be connected to the cap while donned on the infant and measurements will commence. After initial CSF diversion, a 0.5 cc volume of ICG solution will injected into the subcutaneous reservoir and measurements will be conducted using the fCTOT for 30 minutes. The fCTOT cap will be removed and NIRF planar imaging will be conducted to detect ICG in the SAS, draining cervical lymph nodes, along the spinal canal, and in the abdomen, where liver signals are expected. The infant will be transported back to the ICU where CSF diversion will continue and daily, 30 minutes NIRF imaging sessions may be conducted to detect ventricular flow into the SAS and liver clearance. Daily NIRF imaging will be performed in the NICU for as long as 7 days or until the ICG has cleared from the body from liver and/or CSF diversion.

fCTOT and NIRF imaging with ICG

ICG DRUG

The fCTOT cap will be placed on the infant's head . After the MRI, fiber optics will be connected to the cap while donned on the infant and measurements will commence. After initial CSF diversion, a 0.5 cc volume of ICG solution will injected into the subcutaneous reservoir and measurements will be conducted using the fCTOT for 30 minutes. The fCTOT cap will be removed and NIRF planar imaging will be conducted to detect ICG in the SAS, draining cervical lymph nodes, along the spinal canal, and in the abdomen, where liver signals are expected. The infant will be transported back to the ICU where CSF diversion will continue and daily, 30 minutes NIRF imaging sessions may be conducted to detect ventricular flow into the SAS and liver clearance. Daily NIRF imaging will be performed in the NICU for as long as 7 days or until the ICG has cleared from the body from liver and/or CSF diversion.

fCTOT and NIRF imaging with ICG

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Eva Sevick: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Manish Shah, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manish Shah, MD

CONTACT

(713) 500-7370; Manish.N.Shah@uth.tmc.edu

Fred C Velasquez

CONTACT

713-500-3645; Fred.Christian.Velasquez@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: January 14, 2025
• Primary Completion (Estimated): January 3, 2029
• Study Completion (Estimated): January 3, 2029
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)