Pilot Study of Improved Diagnosis and Monitoring of Hydrocephalus in Neonates and Infants Using Contrast-Enhanced Ultrasound
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: 1
Healthy Volunteers: f
View:
• 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/Legally authorized representative permission.
Locations
United States
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Contact Information
Primary
Misun Hwang, MD
hwangm@chop.edu
267-425-7110
Backup
Maria Mezher, MD
mezherm@chop.edu
267-425-5821
Time Frame
Start Date:2025-10-01
Estimated Completion Date:2027-08-01
Participants
Target number of participants:20
Treatments
Experimental: Brain contrast-enhanced ultrasound
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.