drugset / Trial / NCT06693752

CEUS Evaluation of Hydrocephalus in Neonates and Infants

NCT06693752

Phase 2 Recruiting 20 enrolled Children's Hospital of Philadelphia
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2026-07-15
Primary completion
2027-08-01
Completion
2028-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Lumason Diagnostic / imaging agent 0.03 mg/kg Intravenous
Subject Lumason Diagnostic / imaging agent 0.03 ml Intravenous

Indications