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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

Must not have

Pulmonary insufficiency as defined by FiO2 requirements of >40% and/or subjects with pulmonary hypertension requiring nitric oxide

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

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.

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.

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

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I have or might have necrotizing enterocolitis.

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I am 1.5 years old or younger.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need extra oxygen or have high blood pressure in my lungs.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CEUS technique use to detect early alterations in bowel perfusion in Necrotizing Enterocolitis (NEC)

Secondary study objectives

Diagnostic quality of the CEUS exams

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 3Eligibility criteria met