Evaluating CSF Flow in Premature Infants with Hydrocephalus

Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus

This study is trying to see if a special dye can help doctors understand how cerebrospinal fluid flows in premature infants with hydrocephalus and if inflammation affects this flow.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: N/A to 6 Months
• Sex: All
• Sponsor: The University of Texas Health Science Center, Houston (other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06994949 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and efficacy of using indocyanine green (ICG) to evaluate cerebrospinal fluid (CSF) flow dynamics in premature infants diagnosed with post-hemorrhagic hydrocephalus (PHH). The approach involves ventricular microdosing of ICG and utilizing advanced imaging techniques such as fluorescent Cap-based Transcranial Optical Tomography (fCTOT) and Near-InfraRed Fluorescent (NIRF) imaging. The study will also investigate inflammation markers in the CSF and their correlation with CSF dynamics and clinical outcomes, providing insights into how inflammation affects CSF outflow. This is a Phase 1 interventional study focusing on a vulnerable pediatric population.

Who should consider this trial

Good fit: Ideal candidates for this study are premature infants currently in the NICU with a diagnosis of post-hemorrhagic hydrocephalus who have undergone ventricular reservoir placement.

Not a fit: Patients who are clinically unstable or unsuitable for imaging, or those with allergies to iodine or ICG, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of CSF flow issues in premature infants with hydrocephalus.

How similar studies have performed: While this approach is innovative, there is limited information on similar studies, indicating that this may be a novel investigation in this specific context.

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

Where this trial is running

Houston, Texas

• The University of Texas Health Science Center at Houston — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Manish Shah, MD — The University of Texas Health Science Center, Houston
• Study coordinator: Manish Shah, MD

Conditions: Post-hemorrhagic Hydrocephalus, cerebrospinal fluid, premature infants, indocyanine green