Actively Recruiting
Pilot Study of Improved Diagnosis and Monitoring of Hydrocephalus in Neonates and Infants Using Contrast-Enhanced Ultrasound
Led by Children's Hospital of Philadelphia · Updated on 2026-04-20
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hydrocephalus is a condition affecting up to 2 out of every 500 births and can cause long-term disability in many affected infants. This research aims to evaluate the safety and feasibility of using brain contrast-enhanced ultrasound (CEUS) in neonates and infants who have diagnosed or suspected hydrocephalus. Current standard care involves invasive shunts to relieve pressure, but better imaging tools are needed to assess brain health more accurately in this population. The study uses Lumason, a contrast agent injected through an existing intravenous line at a dose of up to 0.03 mg/kg, repeated twice per scan to improve image quality. The CEUS scans will capture dynamic brain blood flow and static images for analysis. The study allows up to two CEUS exams per participant within 1 to 2 weeks, each lasting about 1 hour and 30 minutes including the scan and monitoring. Participants will be monitored for safety for 60 minutes after each contrast agent administration. Imaging data will be analyzed both qualitatively by blinded radiologists and quantitatively using advanced post-processing techniques. The study will measure the feasibility and safety of CEUS scans and explore how ultrasound parameters relate to intracranial pressure and brain ischemia markers over the course of the study.
CONDITIONS
Brief Title
CEUS Evaluation of Hydrocephalus in Neonates and Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females younger than 1.5 years old with diagnosed and/or suspected hydrocephalus
- Post menstrual age of 26 weeks or older
- Inpatients at the Children's Hospital of Philadelphia
- Parental or legally authorized representative permission
You will not qualify if you...
- History of allergic reaction to Lumason contrast agent
- Hemodynamic instability with rapid increase in heart or lung support in past 12-24 hours
- Respiratory instability with rapid increase in respiratory support in past 12-24 hours
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 hours per CEUS exam including preparation, scanning, and monitoring
Participants undergo brain contrast-enhanced ultrasound (CEUS) examinations using a contrast agent to assess brain perfusion and intracranial pressure in infants with hydrocephalus.
1 to 2 CEUS exams within 1 to 2 weeks, each followed by 60 minutes of monitoring
Trial Site Locations
Total: 1 location
1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
M
Misun Hwang, MD
M
Maria Mezher, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Frequently Asked Questions
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