Study of Brain Ultrasound Using Contrast Agent for Diagnosis and Monitoring of Hydrocephalus in Babies and Young Children

What this Trial Is About

Hydrocephalus is a condition affecting up to 2 out of every 500 births and can lead to long-term disability in many affected infants. This study evaluates the safety and feasibility of using brain contrast-enhanced ultrasound CEUS to assess brain health in neonates and infants diagnosed with or suspected of having hydrocephalus. Current methods for deciding when to divert cerebrospinal fluid rely on ventricular size and symptoms, which are not reliable indicators of brain health in this population. Participants will receive brain CEUS scans using Lumason, a contrast agent approved by the FDA for other uses and considered to have a low risk of adverse effects. The contrast agent is administered via an existing intravenous line at a dose of up to 0.03 mgkg, repeated twice during each scan to improve image quality. The study may include up to two CEUS exams per participant, spaced 1 to 2 weeks apart, with each session lasting up to 30 minutes plus a 60-minute monitoring period after contrast administration. During the study, participants will undergo pre-contrast imaging, CEUS scans, and post-scan monitoring for any side effects. Researchers will analyze the scans visually and quantitatively to assess brain blood flow and correlate CEUS findings with invasive measurements of intracranial pressure and brain ischemia markers. The study will measure the safety and feasibility of CEUS and explore its potential as a diagnostic tool in infants with hydrocephalus. Participation will end after the final monitoring period following the last CEUS exam.

CEUS Evaluation of Hydrocephalus in Neonates and Infants