Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus

PHASE1RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 14, 2025

Primary Completion Date

January 3, 2029

Study Completion Date

January 3, 2029

Conditions
Post-hemorrhagic Hydrocephalus (PHH)
Interventions
DEVICE

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.

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.

DRUG

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.

Trial Locations (1)

77030

RECRUITING

The University of Texas Health Science Center at Houston, Houston

All Listed Sponsors
collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

lead

Eva Sevick

OTHER