RecruitingPhase 1

Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus

United States20 participantsStarted 2025-01-14

Plain-language 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.

Who can participate

Age range6 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

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

Timeframe: end 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 examination

Timeframe: end 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 examination

Timeframe: end of study (about 10 days form baseline)

Trial details

NCT IDNCT06994949

SponsorEva Sevick

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-01-03

Contact for this trial

Manish Shah, MD

(713) 500-7370 Manish.N.Shah@uth.tmc.edu

View on ClinicalTrials.gov More Post-hemorrhagic Hydrocephalus (PHH) trials

Plain-language summary

Who can participate

Age range6 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Timeframe: end 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 examination

Timeframe: end of study (about 10 days form baseline)