Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis

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

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

Study Overview

• Status: Completed
• Conditions: Necrotizing Enterocolitis
• Intervention / Treatment: Diagnostic test: Abdominal radiograph; Diagnostic test: Bowel Ultrasound

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.

• Study Type: Interventional
• Enrollment (Actual): 169
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64086
      • Children's Mercy Kansas City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AXR Arm 1; Abdomen Radiograph	Diagnostic test: Abdominal radiograph; Abdominal radiograph
Active Comparator: AXR + BUS Arm 2; Abdomen Radiograph + Bowel Ultrasound	Diagnostic test: Abdominal radiograph; Abdominal radiograph; Diagnostic test: Bowel Ultrasound; Bowel Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days to Full Enteral Feeds: Extended Rule Out Group	Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds	Within 30 days of NEC concern
Days to Full Enteral Feeds: Quick Rule Out Group	Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds	Within 30 days of NEC concern
Days to Full Enteral Feeds: NEC Ruled In	Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds	Within 30 days of NEC concern

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days to End Bowel Rest: Extended Rule Out Group	Number of days infants were kept nil per os (without enteral feeds) following concern for NEC	within 14 days of NEC concern
Days to End Bowel Rest: Quick Rule Out Group	Number of days infants were kept nil per os (without enteral feeds) following concern for NEC	within 14 days of NEC concern
Days to End Bowel Rest: NEC Ruled In	Number of days infants were kept nil per os (without enteral feeds) following concern for NEC	within 14 days of NEC concern
Days to End Antibiotics: Extended Rule Out	Number of days infants received antibiotic therapy initiated for NEC concern	within 14 days of NEC concern
Days to End Antibiotics: Quick Rule Out	Number of days infants received antibiotic therapy initiated for NEC concern	within 14 days of NEC concern
Days to End Antibiotics: NEC Rule In	Number of days infants received antibiotic therapy initiated for NEC concern	within 14 days of NEC concern

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Collaborators: University of Kansas Medical Center; American College of Radiology
• Investigators: Principal Investigator: Sherwin Chan, MD, PhD, Children's Mercy Kansas City

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): September 23, 2024
• Study Completion (Actual): September 18, 2025

Study Registration Dates

• First Submitted: September 23, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 7, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Enterocolitis; Enterocolitis, Necrotizing
• Other Study ID Numbers: STUDY00002293

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No