RECRUITING Phase 2 ClinicalTrials.gov

CEUS Evaluation of Hydrocephalus in Neonates and Infants

Sponsor: Children's Hospital of Philadelphia • ClinicalTrials.gov ID: NCT06693752

Registry updated: 2026-09-16

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Description

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.

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.

Eligibility criteria

Inclusion Criteria: 1. Males and females younger than 1.5 years old with diagnosed and/or suspected hydrocephalus. 2. Post menstrual age of 26 weeks or older. 3. Inpatients at the Children's Hospital of Philadelphia. 4. Parental/Legally authorized representative permission. Exclusion Criteria: 1. Medical history of Lumason hypersensitivity. 2. Hemodynamic instability as defined by rapid escalation of cardiopulmonary support in the past 12-24 hours, as defined by the clinical care team. 3. Respiratory instability as defined by rapid escalation of respiratory support in the past 12-24 hours (Increased fraction of inspired oxygen (FiO2) requirement and/or nitric oxide).

Conditions

Hydrocephalus in Infants Hydrocephalus Acquired

Locations

Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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