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RECRUITING
NCT06693752
PHASE2

CEUS Evaluation of Hydrocephalus in Neonates and Infants

Sponsor: Children's Hospital of Philadelphia

View on ClinicalTrials.gov

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.

Official title: Pilot Study of Improved Diagnosis and Monitoring of Hydrocephalus in Neonates and Infants Using Contrast-Enhanced Ultrasound

Key Details

Gender

All

Age Range

1 Minute - 18 Months

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-03-31

Completion Date

2027-08-01

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

DRUG

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

Injection of Sulfur hexafluoride lipid-type A microspheres contrast agent will be performed via the existing peripheral intravenous line using the FDA-recommended dose of 0.03 mg/kg before performing the contrast-enhanced ultrasound. The weight-based dose of 0.03 mL per kg will be repeated one time during a single examination. Following each injection, an intravenous flush of 0.9% Sodium Chloride is injected.

Locations (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States