Recruiting
Phase 2

Hydrocephalus Evaluation

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT06693752

Conditions

Hydrocephalus in Infants

Hydrocephalus Acquired

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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.

Conditions

Hydrocephalus in Infants

Hydrocephalus Acquired

Study ID

NCT06693752

Start date

Aug 15, 2026

Status verified date

Jul, 2026

Completion date

Aug 1, 2028

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Misun Hwang, MD

267-425-7110hwangm@chop.edu

Maria Mezher, MD

267-425-5821mezherm@chop.edu

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Misun Hwang, MD

267-425-7110hwangm@chop.edu

Maria Mezher, MD

267-425-5821mezherm@chop.edu

Principal Investigator:

Misun Hwang, MD

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • Ultrasound
  • Contrast-enhanced ultrasound
  • Infant hydrocephalus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-07-24.