Contrast ultrasound of the brain in babies with hydrocephalus

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for babies younger than 1.5 years old with diagnosed or suspected hydrocephalus (fluid build-up in the brain). They must be inpatients at the Children's Hospital of Philadelphia.

Age

From 1 Minute to 18 Months (younger than 1.5 years old). Post menstrual age of 26 weeks or older.

Sex

Boys and girls can join.

Disease stage

Diagnosed or suspected hydrocephalus.

Main reasons for not taking part

• Past allergic reaction to Lumason
• Unstable heart and blood flow, with a fast increase in heart or lung support in the past 12-24 hours
• Unstable breathing, with a fast increase in breathing support in the past 12-24 hours (more oxygen and/or nitric oxide)

The registry criteria, word for word

What the trial wants to find out

Hydrocephalus affects up to 2 out of every 500 births and results in long-term disability in up to 78% of those affected. The standard treatment of hydrocephalus is cerebrospinal fluid (CSF) diversion via placement of an invasive ventricular shunt to relieve elevated intracranial pressure (ICP). The clinical decision for CSF diversion is based on the ventricular size and clinical symptoms which are not robust indicators of brain health in neonatal hydrocephalus. The purpose of this study is to assess the safety and feasibility of performing brain contrast-enhanced ultrasound (CEUS) in neonates and infants with diagnosed and/or suspected hydrocephalus.

The group in the trial

• Brain contrast-enhanced ultrasoundTreatment being tested

  The study duration per subject will be up to 30 minutes including the time to prepare the contrast agent, perform the pre-contrast imaging and the contrast-enhanced ultrasound (CEUS), as well as the 60-minute monitoring period after the administration of the contrast agent. A second CEUS exam may be performed within 1-2 weeks from the first scan for up to two CEUS exams of 1 hour and 30-minute duration each. Study participation will be complete when the 60-minute monitoring period of the last CEUS performed is complete.

  Treatment: Sulfur Hexafluoride Lipid Type A Microspheres 25 mg Injection Powder for Suspension [LUMASON]