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CEUS for Hypoxic-Ischemic Brain Injury

Q: To be clear, who meets the requirements to join this test group?

The study is looking for 200 individuals that have suffered brain damage due to various causes. The patients must meet the following requirements: they must be post-menstrual, at least 34 weeks old, currently in either the CHOP NICU or PICU, and finally, they must be 1.5 years old or younger with open fontanelles and a known or suspected history of hypoxic ischemic injury.

Q: Are there current vacancies in this clinical trial?

Yes, as reflected on clinicaltrials.gov, this study is still looking for participants. The posting went up on December 1st 2020 with the most recent update being September 15th 2022. They are hoping to recruit 200 individuals from a single site.

Q: Does this controlled experiment have an age limit for participants?

This particular trial is only for infants aged one minute to 18 months old. Out of the 583 trials available, 112 are specifically geared towards this age group.

Phase 3

Recruiting

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females aged 1.5 years or younger with open fontanelles and known or suspected hypoxic ischemic injury

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is being conducted to evaluate the use of contrast-enhanced ultrasound (CEUS) in bedside monitoring of neonates and infants with hypoxic ischemic injury.

Who is the study for?

This trial is for babies and toddlers up to 1.5 years old with open fontanelles who are suspected of having brain injuries due to lack of oxygen or blood flow, and are in the CHOP NICU or PICU. They must be at least 34 weeks post menstrual age, have parental permission, and not have a history of Lumason hypersensitivity or recent severe cardiopulmonary instability.Check my eligibility

What is being tested?

The study tests how well contrast-enhanced ultrasound (CEUS) can monitor brain perfusion in young patients with hypoxic ischemic injury. It involves two CEUS scans: one when the injury is first suspected/diagnosed and another during an MRI scan.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to the sulfur hexafluoride lipid-type A microspheres used in CEUS. However, specific side effects aren't detailed here as it's primarily a diagnostic procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is 1.5 years or younger with a soft spot on their head and may have brain injury due to lack of oxygen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Qualitative and quantitative assessment of CEUS evaluation of brain perfusion

Trial Design

1Treatment groups

Experimental Treatment

Group I: Contrast-enhanced UltrasonographyExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sulfur hexafluoride

FDA approved

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor

708 Previous Clinical Trials

8,580,859 Total Patients Enrolled

Bracco Diagnostics, IncIndustry Sponsor

60 Previous Clinical Trials

11,163 Total Patients Enrolled

Media Library

Sulfur hexafluoride lipid-type A microspheres Clinical Trial Eligibility Overview. Trial Name: NCT03549520 — Phase 3

Hypoxic-Ischemic Encephalopathy Research Study Groups: Contrast-enhanced Ultrasonography

Hypoxic-Ischemic Encephalopathy Clinical Trial 2023: Sulfur hexafluoride lipid-type A microspheres Highlights & Side Effects. Trial Name: NCT03549520 — Phase 3

Sulfur hexafluoride lipid-type A microspheres 2023 Treatment Timeline for Medical Study. Trial Name: NCT03549520 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other medical studies have used Sulfur hexafluoride lipid-type A microspheres?

"Currently, there are 16 ongoing studies investigating the effects of Sulfur hexafluoride lipid-type A microspheres. Out of these 16 trials, 3 are in Phase 3. Many of the locations for these tests are situated in Salt Lake City, Utah; although, 20 different sites across America are conducting trials for Sulfur hexafluoride lipid-type A microspheres."

Answered by AI

How many patients are enrolling in this clinical trial?

"That is correct, currently the listed information on clinicaltrials.gov says that this study is looking for more patients. The first posting was on December 1st 2020 with the most recent update being September 15th 2022. They are recruiting for 200 participants from 1 site."

Answered by AI

What are the risks associated with Sulfur hexafluoride lipid-type A microspheres?

"Sulfur hexafluoride lipid-type A microspheres have undergone Phase 3 clinical trials, which implies that there is available data to support its efficacy and safety."

Answered by AI

Has this type of drug testing been done before?

"At the moment, there are 16 ongoing studies for Sulfur hexafluoride lipid-type A microspheres being conducted in 10 cities and 3 countries. The very first study was completed in 2017 by Bracco Diagnostics, Inc. This particular trial had 125 participants and finished its Phase < 1 stage of drug approval. Consequently, 21 more studies have been completed since then."

Answered by AI

To be clear, who meets the requirements to join this test group?

"The study is looking for 200 individuals that have suffered brain damage due to various causes. The patients must meet the following requirements: they must be post-menstrual, at least 34 weeks old, currently in either the CHOP NICU or PICU, and finally, they must be 1.5 years old or younger with open fontanelles and a known or suspected history of hypoxic ischemic injury."

Answered by AI

Are there current vacancies in this clinical trial?

"Yes, as reflected on clinicaltrials.gov, this study is still looking for participants. The posting went up on December 1st 2020 with the most recent update being September 15th 2022. They are hoping to recruit 200 individuals from a single site."

Answered by AI

Does this controlled experiment have an age limit for participants?

"This particular trial is only for infants aged one minute to 18 months old. Out of the 583 trials available, 112 are specifically geared towards this age group."

Answered by AI

Recent research and studies

PediatricsJournal

Advanced Ultrasound Techniques for Pediatric Imaging

Hwang, Misun, Maciej Piskunowicz, and Kassa Darge. 2019. “Advanced Ultrasound Techniques for Pediatric Imaging”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2018-2609.

clinicaltrials.govStudy

CEUS Evaluation of Hypoxic Ischemic Injury

Misun Hwang, MD 2020. "CEUS Evaluation of Hypoxic Ischemic Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03549520.

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