Trial Outcomes & Findings for CEUS Evaluation of Bowel Perfusion in Necrotizing Enterocolitis (NCT NCT03549507)

NCT ID: NCT03549507

Last Updated: 2024-11-12

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 1 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2024-11-12

Participant Flow

Participant milestones

Measure	Bowel 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 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. 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. 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.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CEUS Evaluation of Bowel Perfusion in Necrotizing Enterocolitis

Baseline characteristics by cohort

Measure	Contrast-enhanced Ultrasonography n=1 Participants 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. 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. 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.
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	47 Days STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: One subject was enrolled, therefore, no comparison was possible. The enrolled subject presented with medical NEC. Main reasons for lack of enrollment were the presence of clinical instability and/or pulmonary insufficiency/hypertension.

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

Outcome measures

Measure	Bowel Contrast-enhanced Ultrasonography n=1 Participants Intravenous administration of contrast agent Sulfur hexafluoride lipid-type A microspheres before performing CEUS through an existing peripheral intravenous line using the FDA-recommended dose of 0.03 mg/kg. Two bolus injections will be performed and several 2-minute cine clips as well as static images will be acquired during the exam.
Early Detection of Altered Bowel Perfusion Using CEUS Patients with NEC who underwent CEUS examination	1 Number of patients
Early Detection of Altered Bowel Perfusion Using CEUS Patients without NEC who underwent CEUS examination	0 Number of patients

SECONDARY outcome

Timeframe: 2 years

Population: Evaluation of CEUS diagnostic quality

Scoring system of non-diagnostic (1), moderate artifacts degrading diagnostic quality (2), mild artifacts without degradation of diagnostic quality (3), and diagnostic (4).

Outcome measures

Measure	Bowel Contrast-enhanced Ultrasonography n=1 Participants Intravenous administration of contrast agent Sulfur hexafluoride lipid-type A microspheres before performing CEUS through an existing peripheral intravenous line using the FDA-recommended dose of 0.03 mg/kg. Two bolus injections will be performed and several 2-minute cine clips as well as static images will be acquired during the exam.
Number of Participants With Completed CEUS Exams, Categorized by Diagnostic-Quality Scoring System Non-diagnostic	0 Number of participants
Number of Participants With Completed CEUS Exams, Categorized by Diagnostic-Quality Scoring System Mild artifacts without degradation of diagnostic quality	0 Number of participants
Number of Participants With Completed CEUS Exams, Categorized by Diagnostic-Quality Scoring System Moderate artifacts degrading diagnostic quality	1 Number of participants
Number of Participants With Completed CEUS Exams, Categorized by Diagnostic-Quality Scoring System Diagnostic	0 Number of participants

Adverse Events

Bowel Contrast-enhanced Ultrasonography

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Misun Hwang

Children's Hospital of Philadelphia

Phone: 267-425-7129

Email: hwangm@chop.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place