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| ID | Type | Description | Link |
|---|---|---|---|
| R01NS126437 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fCTOT and NIRF imaging with ICG | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of pro-inflammatory cytokines measured in pg/ml | 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 | end of study (about 10 days form baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Manish Shah, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 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. |
|
| 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. |
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| D000091642 | Urogenital Diseases |