Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis

Study Overview
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Brief Summary
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The overall objective of our study is to determine the clinical usefulness of BUS for NEC evaluation in diverse NICU settings.

Detailed Description
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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.

Official Title
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Comparative Effectiveness Trial of Bowel Ultrasound and Abdominal Radiograph Versus Abdominal Radiograph Alone for Diagnosis of Necrotizing Enterocolitis

Conditions
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Necrotizing Enterocolitis

Intervention / Treatment
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* Diagnostic Test: Bowel Ultrasound
* Diagnostic Test: Abdominal radiograph


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AXR Arm 1<br>Abdomen Radiograph | Diagnostic Test: Abdominal radiograph<br>* Abdominal radiograph<br>|
| Active Comparator: AXR + BUS Arm 2<br>Abdomen Radiograph + Bowel Ultrasound | Diagnostic Test: Bowel Ultrasound<br>* Bowel Ultrasound<br>Diagnostic Test: Abdominal radiograph<br>* Abdominal radiograph<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion, an average of 2 years |