NCT06994949 Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus
| NCT ID | NCT06994949 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Eva Sevick |
| Condition | Post-hemorrhagic Hydrocephalus (PHH) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-01-14 |
| Primary Completion | 2029-01-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2025-01-14 with a primary completion date of 2029-01-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Manish Shah, MD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT06994949 clinical trial?
This trial is open to participants of all sexes, up to 6 Months, studying Post-hemorrhagic Hydrocephalus (PHH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06994949 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06994949 currently recruiting?
Yes, NCT06994949 is actively recruiting participants. Contact the research team at Manish.N.Shah@uth.tmc.edu for enrollment information.
Where is the NCT06994949 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06994949 clinical trial?
NCT06994949 is sponsored by Eva Sevick. The principal investigator is Manish Shah, MD at The University of Texas Health Science Center, Houston. The trial plans to enroll 20 participants.