Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis
Primary Purpose
Necrotizing Enterocolitis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bowel Ultrasound
Abdominal radiograph
Sponsored by
About this trial
This is an interventional diagnostic trial for Necrotizing Enterocolitis
Eligibility Criteria
Inclusion Criteria
- Preterm infants ≤ 32 weeks' gestational age at birth
- Admitted to the NICU at CMKC or KUMC
- With clinical suspicion for NEC for which further imaging evaluation was decided by treating neonatologist
Exclusion Criteria
• Infants with major gastrointestinal anomalies such as gastroschisis or omphalocele that prevent BUS from being performed
Sites / Locations
- Children's Mercy Kansas CityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
AXR Arm 1
AXR + BUS Arm 2
Arm Description
Abdomen Radiograph
Abdomen Radiograph + Bowel Ultrasound
Outcomes
Primary Outcome Measures
Impact of imaging algorithm on diagnostic thinking
Determine the impact of AXR vs AXR + BUS for NEC evaluation on diagnostic thinking of neonatologists as measured by pre and post imaging surveys asking about diagnostic thinking and confidence using a Likert scale.
Secondary Outcome Measures
Full Information
NCT ID
NCT05573113
First Posted
September 23, 2022
Last Updated
December 5, 2022
Sponsor
Children's Mercy Hospital Kansas City
Collaborators
University of Kansas Medical Center, American College of Radiology
1. Study Identification
Unique Protocol Identification Number
NCT05573113
Brief Title
Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis
Official Title
Comparative Effectiveness Trial of Bowel Ultrasound and Abdominal Radiograph Versus Abdominal Radiograph Alone for Diagnosis of Necrotizing Enterocolitis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Mercy Hospital Kansas City
Collaborators
University of Kansas Medical Center, American College of Radiology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The overall objective of our study is to determine the clinical usefulness of BUS for NEC evaluation in diverse NICU settings.
Detailed Description
Bowel ultrasound (BUS) for NEC evaluation is a non-invasive imaging modality that allows real-time assessment of the intestinal wall, vascular perfusion, peristalsis, and abdominal fluid. Advantages of BUS is it is non-invasive, does not have radiation, does not require special preparation before procedure, and is well tolerated even by sick preterm infants. BUS is already being used in centers that have sufficient BUS expertise as an alternative standard of care approach for evaluating NEC, but in a highly variable manner.
Standard ultrasound equipment is all that is needed for BUS. Pre-study training will be conducted for sonographers to acquire the study BUS images using standardized technique. Pre-study training of radiologists will also be conducted to standardize the interpretation of BUS findings for NEC. All BUS for NEC ordering, acquisition, and interpretation in the study will be the same as the standard workflow for any other imaging ordered in the clinical setting. All BUS performed as part of the study will not be charged to patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotizing Enterocolitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AXR Arm 1
Arm Type
Active Comparator
Arm Description
Abdomen Radiograph
Arm Title
AXR + BUS Arm 2
Arm Type
Active Comparator
Arm Description
Abdomen Radiograph + Bowel Ultrasound
Intervention Type
Diagnostic Test
Intervention Name(s)
Bowel Ultrasound
Intervention Description
Bowel Ultrasound
Intervention Type
Diagnostic Test
Intervention Name(s)
Abdominal radiograph
Intervention Description
Abdominal radiograph
Primary Outcome Measure Information:
Title
Impact of imaging algorithm on diagnostic thinking
Description
Determine the impact of AXR vs AXR + BUS for NEC evaluation on diagnostic thinking of neonatologists as measured by pre and post imaging surveys asking about diagnostic thinking and confidence using a Likert scale.
Time Frame
Through study completion, an average of 2 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Preterm infants ≤ 32 weeks' gestational age at birth
Admitted to the NICU at CMKC or KUMC
With clinical suspicion for NEC for which further imaging evaluation was decided by treating neonatologist
Exclusion Criteria
• Infants with major gastrointestinal anomalies such as gastroschisis or omphalocele that prevent BUS from being performed
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maura Sien, MS, RT(R)
Phone
18163026065
Email
mesien@cmh.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amie Robinson, MBA RT(R)(MR)
Phone
8163028311
Email
alrobinson@cmh.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherwin Chan, MD, PhD
Organizational Affiliation
Children's Mercy Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64086
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maura Sien
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis
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