RECRUITING

Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus

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Conditions

Post-hemorrhagic Hydrocephalus (PHH)cerebrospinal fluid (CSF)premature infantsindocyanine green (ICG)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus

Quick Facts

Study Start:2025-01-14
Study Completion:2029-01-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06994949

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 6 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Children born premature currently in the NICU with a diagnosis of PHH who have undergone ventricular reservoir placement.
  2. * 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.
  1. * Parents who do not consent for procedure on their child
  2. * 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)
  3. * Children known or suspected to have allergy to iodine or ICG
  4. * Children who do not have a subcutaneous reservoir for CSF diversion from the lateral ventricle

Contacts and Locations

Study Contact

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

Principal Investigator

Manish Shah, MD
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston

Study Locations (Sites)

The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Eva Sevick

  • Manish Shah, MD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-14
Study Completion Date2029-01-03

Study Record Updates

Study Start Date2025-01-14
Study Completion Date2029-01-03

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Post-hemorrhagic Hydrocephalus (PHH)