Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis

Necrotizing Enterocolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05573113
• Other study ID #: STUDY00002293
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Children's Mercy Hospital Kansas City
• Contact: Maura Sien, MS, RT(R)
• Phone: 18163026065
• Email: mesien[@]cmh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis

Intervention

Diagnostic Test:
• Bowel Ultrasound
Bowel Ultrasound
• Abdominal radiograph
Abdominal radiograph

Locations

Country	Name	City	State
United States	Children's Mercy Kansas City	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City	American College of Radiology, University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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