CEUS Evaluation of Hydrocephalus in Neonates and Infants

Conditions

• Hydrocephalus Acquired
• Hydrocephalus in Infants

Eligibility Criteria

Sex

ALL

Age

1 Minute - 18 Months

Healthy Volunteers

Not accepted

Interventions

• Sulfur Hexafluoride Lipid Type A Microspheres 25 mg Injection Powder for Suspension [LUMASON] — DRUG
  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.

Study Details

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.

Key Dates

Start date

May 5, 2026

Status verified

Apr 2026

Primary completion

Aug 1, 2026

Completion

Aug 1, 2027

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• 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.

Primary Outcome Measure

Feasibility of brain contrast-enhanced ultrasound (CEUS) examinations in infants with hydrocephalus [ Time Frame: Up to 2 years ]

Central Contacts

• Misun Hwang, MD
  267-425-7110
  [email protected]
• Maria Mezher, MD
  267-425-5821
  [email protected]

Locations (1)

Find similar trials in Philadelphia, PA

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• Non-Invasive Pressure Monitor for Neonates & Infants at Risk of Developing Hydrocephalus
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