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Completed

NCT Number: NCT05573113

Comparative Effectiveness Trial 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.

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Key information

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center, Kansas City, Kansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bowel Ultrasound

Diagnostic Test

Bowel Ultrasound

Abdominal radiograph

Diagnostic Test

Abdominal radiograph

Primary outcomes

  1. Days to Full Enteral Feeds: Extended Rule Out Group

    Time frame: Within 30 days of NEC concern

    Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds

  2. Days to Full Enteral Feeds: Quick Rule Out Group

    Time frame: Within 30 days of NEC concern

    Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds

  3. Days to Full Enteral Feeds: NEC Ruled In

    Time frame: Within 30 days of NEC concern

    Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds

Secondary outcomes

  1. Days to End Bowel Rest: Extended Rule Out Group

    Time frame: within 14 days of NEC concern

    Number of days infants were kept nil per os (without enteral feeds) following concern for NEC

  2. Days to End Bowel Rest: Quick Rule Out Group

    Time frame: within 14 days of NEC concern

    Number of days infants were kept nil per os (without enteral feeds) following concern for NEC

  3. Days to End Bowel Rest: NEC Ruled In

    Time frame: within 14 days of NEC concern

    Number of days infants were kept nil per os (without enteral feeds) following concern for NEC

  4. Days to End Antibiotics: Extended Rule Out

    Time frame: within 14 days of NEC concern

    Number of days infants received antibiotic therapy initiated for NEC concern

  5. Days to End Antibiotics: Quick Rule Out

    Time frame: within 14 days of NEC concern

    Number of days infants received antibiotic therapy initiated for NEC concern

  6. Days to End Antibiotics: NEC Rule In

    Time frame: within 14 days of NEC concern

    Number of days infants received antibiotic therapy initiated for NEC concern

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Collaborators

  • American College of Radiology
  • University of Kansas Medical Center

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Oct 10, 2022
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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