CEUS Evaluation of Bowel Perfusion in Necrotizing Enterocolitis

NCT03549507 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: 18-014910
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

There is no bedside imaging technique that can quantify dynamic bowel perfusion with high soft tissue contrast and sensitivity in necrotizing enterocolitis (NEC). Our goal is to assess the feasibility of utilizing contrast-enhanced ultrasound (CEUS) in bedside monitoring of bowel perfusion in NEC. Patients with suspected or diagnosed NEC will be recruited for the study. Following parental consent, the subject will undergo CEUS, performed separately from any clinically indicated conventional US, in the ICU. Subjects will be scanned with CEUS at two different time-points (at the time NEC is first suspected or diagnosed and at time of MRI scan). The CEUS scans 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

Necrotizing Enterocolitis of Newborn; Bowel Ischemic

Keywords

Ultrasound; Contrast-enhanced ultrasound

Outcome Measures

Primary Outcomes (1)

• Early Detection of Altered Bowel Perfusion Using CEUS

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

  2 years

Secondary Outcomes (1)

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

  2 years

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 (if there are two injections of contrast) 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. Two bolus injections will be performed to evaluate for dynamic bowel perfusion and several 2-minute cine clips as well as static images will be acquired during the exam.

Contrast-enhanced Ultrasonography

Eligibility Criteria

• Age: 0 Years - 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
• Post menstrual age of 29 weeks or older
• Patients with suspected or diagnosed necrotizing enterocolitis
• 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 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

Results Point of Contact

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

hwangm@chop.edu

267-425-7129

Study Officials

• Misun Hwang, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

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: November 4, 2020
• Primary Completion: May 7, 2024
• Study Completion: May 7, 2024
• Last Updated: November 12, 2024
• Results First Posted: November 12, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)