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CEUS Evaluation of Bowel Perfusion in Necrotizing Enterocolitis

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ClinicalTrials.gov Identifier: NCT03549507
Recruitment Status : Not yet recruiting
First Posted : June 8, 2018
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Misun Hwang, MD, Children's Hospital of Philadelphia

Brief Summary:
There is no bedside imaging technique that can quantify dynamic bowel perfusion with high soft tissue contrast and sensitivity. Investigators will assess the feasibility of utilizing contrast-enhanced ultrasound (CEUS) in bedside monitoring of bowel perfusion in neonatal necrotizing enterocolitis.

Condition or disease Intervention/treatment Phase
Necrotizing Enterocolitis of Newborn Bowel Ischemic Drug: Sulfur hexafluoride lipid-type A microspheres Phase 3

Detailed Description:

Patients scheduled for routine abdominal ultrasound for screening or monitoring of necrotizing enterocolitis will be recruited for the study. The study will be performed at Children's Hospital of Philadelphia (CHOP) in the Department of Radiology. CHOP will be the only site of the study with subjects in the neonatal intensive care unit aged 0 to 1 year of age.

Following consent, the subject will undergo a routine abdominal ultrasound in the main department. After completion of the routine abdominal ultrasound, the CEUS exam will be performed for additional 15 minutes in the same setting. Potential subjects will be identified in two ways: 1) Identification by neonatologists of patients requiring abdominal ultrasound during the neonatal intensive care unit stay for suspected, at risk of or diagnosed necrotizing enterocolitis and 2) Review of ultrasound schedule followed by review of chart.

Before discussing participation in the study, investigators will confirm eligibility by reviewing the subjects' medical records. Participation will be discussed between the Principal Investigator (PI) and the referring neonatologist. Participation will be discussed with the subject and parents/guardian by the neonatologist and/or radiologist after identification and confirmation of eligibility. Consent and assent (if required) will be obtained prior to the exam by the neonatologist (co-investigator) or PI in a private room. Questions will be answered by the PI or referring neonatologist.

After the routine abdominal ultrasound acquisition, the CEUS scan will be performed in the same setting. Subjects may be scanned with CEUS up to two times, at different time points (approximately a week a part), always following standard of care US. Injection of Lumason contrast agent will be performed via the existing peripheral intravenous line using the FDA-recommended dose of 0.03 mg/kg. Up to 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. The imaging criteria for the second bolus dose will be: 1) hyperperistalsis of bowel loops precluding continuous imaging of bowel loops in a given field of view during 1 min video clip of wash-in of contrast 2) technical failures including contrast not reaching the circulation due to inadequate flush in the setting of long IV line or nonfunctioning IV line.

Qualitative analysis with visual assessment and quantitative analysis of the acquired CEUS scans will be performed and interpreted by the PI and reviewed by the second radiologist who is blinded to the reports of the PI. The scans will be assessed for diagnostic quality of images, artifacts encountered, and the presence of additional contributory diagnostic information.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Bowel Perfusion With Contrast-Enhanced Ultrasound in Necrotizing Enterocolitis
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Contrast-enhanced Ultrasonography
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 may 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 30 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
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. Up to 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.




Primary Outcome Measures :
  1. CEUS technique use to detect early alterations in bowel perfusion in Necrotizing Enterocolitis (NEC) [ Time Frame: 2 years ]
    Evaluate whether CEUS technique can be utilized to detect early alterations in bowel perfusion in NEC. The differences in bowel perfusion between normal subjects (those with suspected or at risk of necrotizing enterocolitis but turns out to be normal on imaging and clinical evaluation) versus NEC patients will be assessed qualitatively and quantitatively using the CEUS technique, as detailed above.


Secondary Outcome Measures :
  1. Diagnostic quality of the CEUS exams [ Time Frame: 2 years ]
    Diagnostic quality of the CEUS exams will be evaluated with the scoring system of non-diagnostic (1), moderate artifacts degrading diagnostic quality (2), mild artifacts without degradation of diagnostic quality (3), and diagnostic (4).



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females age 0-1 year
  • Patients scheduled for a clinically indicated abdominal ultrasound for suspected or diagnosed necrotizing enterocolitis
  • Subject consent or parental/guardian permission (informed consent)
  • Subjects who are 36 weeks or older post menstrual age (gestational age + chronologic age)

Exclusion Criteria:

  • Prior allergic reaction to Lumason contrast agent
  • Hemodynamically unstable patients
  • Subjects with cardiac shunts or pulmonary insufficiency
  • Subjects who are intubated and on pressors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549507


Locations
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United States, Pennsylvania
The Children's Hospital of Philadelphia Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Misun Hwang, MD    267-425-7110    hwangm@email.chop.edu   
Contact: Sandra Saade, MD    2674257139    saades@email.chop.edu   
Principal Investigator: Misun Hwang, MD         
Sponsors and Collaborators
Children's Hospital of Philadelphia

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Responsible Party: Misun Hwang, MD, Sponsor Investigator, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03549507     History of Changes
Other Study ID Numbers: IRB 18-014910
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Misun Hwang, MD, Children's Hospital of Philadelphia:
Ultrasound

Additional relevant MeSH terms:
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Enterocolitis
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases