← Back to Search

Sulfur hexafluoride microspheres for Necrotizing Enterocolitis

Phase 3
Recruiting
Led By Misun Hwang, MD
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
Patients with suspected or diagnosed necrotizing enterocolitis
Males and females aged 1.5 years or younger
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is being done to see if using contrast-enhanced ultrasound (CEUS) can help show how well the intestines are perfusing (getting blood flow) in patients with NEC.

Who is the study for?
This trial is for male and female infants up to 1.5 years old, with a postmenstrual age of at least 29 weeks, who are in the NICU or PICU at The Children's Hospital of Philadelphia and have suspected or confirmed necrotizing enterocolitis. Infants with Lumason hypersensitivity, recent hemodynamic instability, or significant pulmonary insufficiency cannot participate.Check my eligibility
What is being tested?
The study tests the use of contrast-enhanced ultrasound (CEUS) using sulfur hexafluoride lipid-type A microspheres to monitor bowel perfusion in infants with necrotizing enterocolitis. It involves two CEUS scans: one when NEC 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 related to this procedure in infants will be monitored closely given their vulnerability.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have or might have necrotizing enterocolitis.
Select...
I am 1.5 years old or younger.

Timeline

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
CEUS technique use to detect early alterations in bowel perfusion in Necrotizing Enterocolitis (NEC)
Secondary outcome measures
Diagnostic quality of the CEUS exams

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 (if there are two injections of contrast) of the contrast agent.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sulfur hexafluoride
FDA approved

Find a Location

Who is running the clinical trial?

Bracco Diagnostics, IncIndustry Sponsor
61 Previous Clinical Trials
11,269 Total Patients Enrolled
Children's Hospital of PhiladelphiaLead Sponsor
710 Previous Clinical Trials
8,588,764 Total Patients Enrolled
Misun Hwang, MDPrincipal Investigator - Children's Hospital of Philadelphia
Children's Hospital of Philadelphia

Media Library

Sulfur hexafluoride lipid-type A microspheres Clinical Trial Eligibility Overview. Trial Name: NCT03549507 — Phase 3
Necrotizing Enterocolitis Research Study Groups: Contrast-enhanced Ultrasonography
Necrotizing Enterocolitis Clinical Trial 2023: Sulfur hexafluoride lipid-type A microspheres Highlights & Side Effects. Trial Name: NCT03549507 — Phase 3
Sulfur hexafluoride lipid-type A microspheres 2023 Treatment Timeline for Medical Study. Trial Name: NCT03549507 — Phase 3
~0 spots leftby Jun 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top