Back to search results

Assessing CSF Flow in Pediatric Hemorrhagic Hydrocephalus

This study is looking at how cerebrospinal fluid (CSF) moves in infants with post-hemorrhagic hydrocephalus (PHH), a condition where bleeding in the brain causes fluid buildup. Researchers will use a special cap called the fCTOT cap, Near-InfraRed Fluorescent (NIRF) imaging, and a small amount of ICG (indocyanine green) solution to track CSF flow. The goal is to understand how inflammation might affect this flow and the success of treatments like Endoscopic Third Ventriculostomy (ETV) or Choroid Plexus Cauterization (CPC). This study is for premature infants up to 6 months old who are in the NICU with PHH and have had a ventricular reservoir placed. The study aims to enroll 20 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 20 participants. It is not specified if it is randomized or blinded.
What's involved
After an MRI, a fCTOT cap will be placed on the infant's head, and measurements will be taken. After initial CSF diversion, a small amount of ICG solution will be injected, and more measurements will be taken.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for about 10 days from baseline to assess ventriculomegaly (enlarged fluid-filled spaces in the brain).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06994949

Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus

Recruiting
PHASE1Up to 6Interventional
Eva Sevick
~20 participants
Updated 2025-05-29 on ClinicalTrials.gov
What's tested:fCTOT capNIRF planar imagingICG

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants 1-2 weeks of age who present with continuing ventriculomegaly after CSF diversion as assessed by the clinical MRI examination
Measured over end of study (about 10 days form baseline)
+2 more outcomes measured

Conditions

Post-hemorrhagic Hydrocephalus (PHH)

Explore related trials

Post-Hemorrhagic Hydrocephalus

Where it's being run

1 sites across 1 states
Texas1

Study leadership

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

Who to contact

Manish Shah, MD
[email protected]
(713) 500-7370
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of participants 1-2 weeks of age who present with continuing ventriculomegaly after CSF diversion as assessed by the clinical MRI examinationend 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 examinationend 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 examinationend of study (about 10 days form baseline)