Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis

NCT05573113 | Completed Results FDA Device

• 1 other identifier: STUDY00002293
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Necrotizing Enterocolitis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Days to End Bowel Rest: Extended Rule Out Group

  within 14 days of NEC concern

• Days to End Bowel Rest: Quick Rule Out Group

  within 14 days of NEC concern

• Days to End Bowel Rest: NEC Ruled In

  within 14 days of NEC concern

• Days to End Antibiotics: Extended Rule Out

  within 14 days of NEC concern

• Days to End Antibiotics: Quick Rule Out

  within 14 days of NEC concern

Study Arms (2)

AXR Arm 1

ACTIVE COMPARATOR

Abdomen Radiograph

Diagnostic Test: Abdominal radiograph

AXR + BUS Arm 2

ACTIVE COMPARATOR

Abdomen Radiograph + Bowel Ultrasound

Diagnostic Test: Bowel Ultrasound; Diagnostic Test: Abdominal radiograph

Interventions

Bowel Ultrasound DIAGNOSTIC_TEST

Bowel Ultrasound

AXR + BUS Arm 2

Abdominal radiograph DIAGNOSTIC_TEST

Abdominal radiograph

AXR + BUS Arm 2; AXR Arm 1

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Admitted to the NICU at CMKC or KUMC
• With clinical suspicion for NEC for which further imaging evaluation was decided by treating neonatologist

You may not qualify if:

• Infants with major gastrointestinal anomalies such as gastroschisis or omphalocele that prevent BUS from being performed

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• University of Kansas Medical Center: collaborator
• American College of Radiology: collaborator

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Children's Mercy Kansas City

Kansas City, Missouri, 64086, United States

Location

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Limitations and Caveats

* Cross-over between study arms occurred. * Study conducted at only two sites; generalizability may be limited. * Some analyses underpowered due to smaller sample size than anticipated.

Results Point of Contact

• Title: Sherwin Chan
• Organization: Children's Mercy Kansas City

sschan@cmh.edu

816-234-3273

Study Officials

• Sherwin Chan, MD, PhD

  Children's Mercy Kansas City

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Radiologist

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: October 10, 2022
• Study Start: November 1, 2022
• Primary Completion: September 23, 2024
• Study Completion: September 18, 2025
• Last Updated: November 21, 2025
• Results First Posted: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)