CEUS Evaluation of Hypoxic Ischemic Injury

NCT03549520 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 18-014912
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Neonates presenting with neurologic symptoms require rapid, non-invasive imaging with high spatial resolution and tissue contrast. The purpose of this study is to evaluate brain perfusion using contrast-enhanced ultrasound CEUS in bedside monitoring of neonates and infants with hypoxic ischemic injury (HII). Investigational CEUS scan will be performed separately from clinically indicated conventional US, in the ICU. Subjects will be scanned with CEUS at two different time-points (at the time HII is first suspected or diagnosed and at time of MRI scan), separately from clinically indicated ultrasound. The CEUS scan will be interpreted by the sponsor-investigator. The study will be conducted at one site, The Children's Hospital of Philadelphia. It is expected that up to 100 subjects will be enrolled per year, for up to two years, for a total enrollment of up to 200 subjects.

Conditions

Hypoxic-Ischemic Encephalopathy; Brain Ischemia Hypoxia

Keywords

Ultrasound; Contrast-enhanced ultrasound

Outcome Measures

Primary Outcomes (1)

• Detection of Brain Perfusion Abnormalities Using Contrast-enhanced Ultrasound

  Comparison of brain perfusion between normal subjects (those with suspected or at risk of HII but turn out to be normal on imaging and clinical evaluation) versus HII patients

  During contrast-enhanced ultrasound examination, up to 15 minutes.

Secondary Outcomes (1)

• Number of Participants With Completed Brain CEUS Exams, Categorized by Diagnostic-Quality Scoring System

  During contrast-enhanced ultrasound examination, up to 15 minutes.

Study Arms (1)

Contrast-enhanced Ultrasonography

EXPERIMENTAL

Intravenous administration of contrast agent Sulfur hexafluoride lipid-type A microspheres before performing contrast-enhanced ultrasound (CEUS). In pediatric patients, after reconstitution 0.03 mL per kg is administered intravenously. 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. The study duration per subject will be approximately 15 minutes including the time to prepare the contrast agent and perform the CEUS, as well as the 60 minute monitoring period after the first and second injection of the contrast agent.

Drug: Sulfur hexafluoride lipid-type A microspheres

Interventions

Sulfur hexafluoride lipid-type A microspheres DRUG

Injection of Sulfur hexafluoride lipid-type A microspheres (Lumason) contrast agent will be performed via the existing peripheral intravenous line using the FDA-recommended dose of 0.03 mg/kg.

Contrast-enhanced Ultrasonography

Eligibility Criteria

• Age: 1 Minute - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males and females aged 1.5 years or younger with open fontanelles and known or suspected hypoxic ischemic injury.
• Post menstrual age of 34 weeks or older
• Patient in the Children's Hospital of Philadelphia (CHOP) Neonatal Intensive Care Unit (NICU) or Pediatric Intensive Care Unit (PICU)
• Parental permission

You may not qualify if:

• Medical history of Lumason hypersensitivity
• Hemodynamic instability as defined by rapid escalation of cardiopulmonary support in the past 12-24 hours, as defined by the clinical care team including ≥ 1 intensive care physician not part of the study team
• Pulmonary insufficiency as defined by fraction of inspired oxygen (FiO2) requirements of \> 40% and/or subjects with pulmonary hypertension requiring nitric oxide

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Bracco Diagnostics, Inc: collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Hwang M, Piskunowicz M, Darge K. Advanced Ultrasound Techniques for Pediatric Imaging. Pediatrics. 2019 Mar;143(3):e20182609. doi: 10.1542/peds.2018-2609.

  PMID: 30808770 DERIVED

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Misun Hwang
• Organization: Children's Hospital of Philadelphia

hwangm@chop.edu

267-425-7129

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 8, 2018
• Study Start: December 1, 2020
• Primary Completion: May 7, 2024
• Study Completion: May 7, 2024
• Last Updated: May 14, 2025
• Results First Posted: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)