Actively Recruiting

Phase 2
Age: 1Minute - 18Months
All Genders
NCT06693752

CEUS Evaluation of Hydrocephalus in Neonates and Infants

Led by Children's Hospital of Philadelphia · Updated on 2026-04-20

20

Participants Needed

1

Research Sites

64 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

CEUS Evaluation of Hydrocephalus in Neonates and Infants

Who Can Participate

Age: 1Minute - 18Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females younger than 1.5 years old with diagnosed and/or suspected hydrocephalus
  • Post menstrual age of 26 weeks or older
  • Inpatients at the Children's Hospital of Philadelphia
  • Parental or legally authorized representative permission
Not Eligible

You will not qualify if you...

  • History of hypersensitivity to Lumason
  • Hemodynamic instability defined by rapid increase in cardiopulmonary support in past 12-24 hours
  • Respiratory instability defined by rapid increase in respiratory support in past 12-24 hours (increased oxygen or nitric oxide)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

M

Misun Hwang, MD

CONTACT

M

Maria Mezher, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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