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Search / Trial NCT06994949

Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus

Launched by EVA SEVICK · May 20, 2025

Trial Information

Current as of July 27, 2025

Recruiting

Keywords

Cerebrospinal Fluid (Csf) Premature Infants Indocyanine Green (Icg)

ClinConnect Summary

This clinical trial is studying a condition called post-hemorrhagic hydrocephalus (PHH) in children, particularly those who were born premature and are currently in the Neonatal Intensive Care Unit (NICU). The main goal of the study is to test a safe method of using a special dye called indocyanine green (ICG) to help doctors see how cerebrospinal fluid (CSF) moves in the brain and how it drains from the body. By using advanced imaging techniques, the researchers hope to learn more about how inflammation affects this fluid flow, which could help improve treatment for these children.

To be eligible for the trial, children must have been born premature, diagnosed with PHH, and have a device called a ventricular reservoir placed to help manage their CSF. The study is currently looking for participants and aims to include children who are stable enough for imaging procedures. Parents will need to give their consent for their child to participate, and children with certain allergies or unstable medical conditions will not be included. If your child qualifies, they may have the opportunity to be part of this important research, which could lead to better understanding and care for similar conditions in the future.

Gender

ALL

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

About Eva Sevick

Eva Sevick is a dedicated clinical trial sponsor specializing in innovative healthcare solutions that prioritize patient safety and efficacy. With a strong focus on advancing medical research, Eva Sevick collaborates with leading research institutions and healthcare professionals to develop and implement clinical trials aimed at addressing unmet medical needs. The organization is committed to maintaining the highest ethical standards and regulatory compliance, ensuring that all studies contribute valuable insights to the medical community while fostering transparency and trust among participants.

Locations

Houston, Texas, United States

Patients applied

0 patients applied

Trial Officials

Manish Shah, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported