Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus

NCT ID: NCT06994949

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-14
• Study Completion Date: 2029-01-03

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

fCTOT and NIRF imaging with ICG

Group Type: EXPERIMENTAL

fCTOT cap

Intervention Type: 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.

NIRF planar imaging

Intervention Type: 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.

ICG

Intervention Type: 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.

Interventions

fCTOT cap

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.

Intervention Type: DEVICE

NIRF planar imaging

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.

Intervention Type: DEVICE

ICG

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Eva Sevick

OTHER

Sponsor Role: lead

Responsible Party

Eva Sevick

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Manish Shah, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Manish Shah, MD

Role: CONTACT

Manish.N.Shah@uth.tmc.edu

(713) 500-7370

Fred C Velasquez

Role: CONTACT

Fred.Christian.Velasquez@uth.tmc.edu

713-500-3645

Facility Contacts

Manish Shah, MD

Role: primary

Manish.N.Shah@uth.tmc.edu

713-500-7370

Fred C Velasquez

Role: backup

Fred.Christian.Velasquez@uth.tmc.edu

713-500-3645

Other Identifiers

R01NS126437

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC-MS-21-0809

Identifier Type: -

Identifier Source: org_study_id