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Recruiting NCT06994949

Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus

Phase I Interventional Post-hemorrhagic Hydrocephalus (PHH)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: fCTOT cap, NIRF planar imaging, ICG.
Who it may be relevant to
Registry conditions: Post-hemorrhagic Hydrocephalus (PHH). Basic parameters: up to 6 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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 th
  • 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 i
  • 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 i

Primary outcome measures

  • Number of participants 1-2 weeks of age who present with continuing ventriculomegaly after CSF diversion as assessed by the clinical MRI examination [Time frame: 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 [Time frame: 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 [Time frame: end of study (about 10 days form baseline)]
Secondary outcome measures (1)
  • Amount of pro-inflammatory cytokines measured in pg/ml [Time frame: end of study (about 10 days form baseline)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT06994949 · HSC-MS-21-0809 · R01NS126437

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗