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Sulfur hexafluoride microspheres for Necrotizing Enterocolitis
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have or might have necrotizing enterocolitis.I need extra oxygen or have high blood pressure in my lungs.I am 1.5 years old or younger.
- Group 1: Contrast-enhanced Ultrasonography
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Can people over the age of 30 participate in this research project?
"The aim of this clinical study is to enroll infants who are less than 18 months old."
Has the FDA cleared the use of Sulfur hexafluoride lipid-type A microspheres?
"Sulfur hexafluoride lipid-type A microspheres have undergone multiple rounds of testing and have been proven effective, so they are estimated to be a 3 on the Power safety scale."
If I qualify, can I sign up for this experiment?
"This study is looking for 200 young patients, below the age of 18 months, that have enterocolitis, necrotizing. Additionally, the following must be true of the patient: they're currently in the Children's Hospital of Philadelphia (CHOP) neonatal intensive care unit (NICU) or pediatric intensive care unit (PICU), they're male or female, and they have a post menstrual age of 29 weeks or more."
How many people are currently being given lenalidomide as part of this study?
"That is correct. The information available on clinicaltrials.gov reveals that this study is still searching for participants. This trial was first posted on November 4th, 2020 and was edited on September 15th, 2022. They are looking for a total of 200 patients from 1 site."
Are people with the relevant medical conditions able to sign up for this clinical trial?
"Based on the information available on clinicaltrials.gov, this trial is still open and looking for participants. The study was first announced on November 4th 2020 with the most recent update on September 15th 2022."
Does this experiment pave the way for more research like it?
"There are currently 16 active studies for Sulfur hexafluoride lipid-type A microspheres in 10 cities and 3 countries. The first clinical trial for Sulfur hexafluoride lipid-type A microspheres was conducted in 2017 and sponsored by Bracco Diagnostics, Inc. The trial involved 125 patients and completed its Phase < 1 drug approval stage. Since 2017, 21 studies have been completed."
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