Evaluating CSF Flow in Premature Infants with Hydrocephalus
Official title: Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus
Run by The University of Texas Health Science Center, Houston · NCT06994949 · Data updated 2026-11-12
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 | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 6 Months |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | January 14, 2025 |
| Main results expected | January 3, 2029 |
| Study ends | January 3, 2029 |
| Registry record updated | May 29, 2025 |
| Trial ID | NCT06994949 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is innovative, there is limited information on similar studies, indicating that this may be a novel investigation in this specific context.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: Manish.N.Shah@uth.tmc.edu
- Phone: (713) 500-7370
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Circadian Variation of Anti-Factor Xa in Trauma Patients on LMWH
This study tests whether anti-Factor Xa levels show a daily rhythm in hospitalized trauma patients receiving LMWH for VTE prevention.
-
PrioritiesAI: A chat tool to help older adults with hernia decide what matters most for surgery
This study tests an AI-powered chat assistant to help people with hernia clearly express and communicate their health goals for elective surgery.
-
Family-based program to reduce risk factors for schizophrenia spectrum disorders in youth with family history
This study tests a brief family-based psychosocial program to see if it lowers persistent psychotic-like experiences in kids and young adults with a family history of SSD and different brain risk patterns.
-
EUS-Guided RFA for Pancreatic Lesions: Safety and Outcomes
This study tests whether using endoscopic ultrasound-guided radiofrequency ablation is safe and helps patients with pancreatic lesions.
-
Skin-to-skin care with the Skincubator for preterm infants
This study tests whether using the Skincubator during skin-to-skin care is safe and feasible for preterm babies and their parents in the NICU.
-
See if iCHAMPSS 2.0 helps schools spread effective sexual health programs
This study tests whether iCHAMPSS 2.0 helps Texas schools implement an evidence-based sexual health program more effectively for teachers, administrators, and health staff.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.