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CEUS Evaluation of Hydrocephalus in Neonates and Infants

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

Who can join

1 Minute – 18 Months · All sexes

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).

About the study

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.

What is being tested

• Sulfur Hexafluoride Lipid Type A Microspheres 25 mg Injection Powder for Suspension [LUMASON] (drug)

Sponsor: Children's Hospital of Philadelphia · Participants: 20 · Started: Oct 15, 2026

Contact the study team

• Misun Hwang, MD · Phone: 267-425-7110
• Maria Mezher, MD · Phone: 267-425-5821

Official record on ClinicalTrials.gov — NCT06693752

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.