NEC Screening Abdominal Radiograph vs Bowel Ultrasound in Preemies

January 6, 2022 updated by: Children's Mercy Hospital Kansas City

Pilot Randomized Control Trial of Necrotizing Enterocolitis Screening Abdominal Radiograph Versus Bowel Ultrasound Plus Abdominal Radiograph in Premature Neonates

The overall primary objective is to establish the feasibility and pilot the design and delivery of a diagnostic randomized controlled trial (RCT) of BUS (bowel ultrasound) for NEC evaluation which will lead to a successful application for a larger, multi-center clinical trial in the future. This program of research is anticipated to have a significant positive impact in the timely and accurate diagnosis of NEC in preterm infants.

Study Overview

Status

Terminated

Intervention / Treatment

Detailed Description

Necrotizing enterocolitis (NEC) is the most common bowel disease in premature and low birth weight neonates. NEC is defined by the loss of mucosal integrity of the bowel wall enabling bacteria and other toxins to permeate into the bowel causing ischemia and necrosis which can lead to bowel perforation and sepsis. NEC can result in substantial morbidity and mortality and prolonged hospital stay.

In the past, abdominal radiography has been scored on a standard scale that correlated with outcomes. Duke University Medical Center developed a standardized ten-point radiographic scale, the Duke Abdominal Assessment Scale (DAAS) (Appendix B) and was proven to be directly proportional to the severity of NEC on patients that underwent surgery. Abdominal radiographs are assessed for gas pattern, bowel distention, location and features, pneumatosis (gas in bowel wall), portal venous gas, and pneumoperitoneum (free air in peritoneal cavity) to indicate the level of suspicion of NEC. The use of abdominal radiographs is the most common assessment for suspected NEC in infants, however, there have been recent studies done on the utility of bowel ultrasound to aid in early diagnosis of NEC due to the ability to evaluate peristalsis, echogenicity and thickness of bowel wall, pneumatosis and the capability of doing color Doppler to evaluate blood perfusion. A University of Toronto study used ultrasound to assess bowel perfusion with color Doppler in neonates and found a correlation between absence of bowel wall perfusion and the increased severity of NEC on surgical pathology. Although there are similar signs found between abdominal radiography and bowel ultrasound, some of the more severe features such as, pneumoperitoneum, were found to be more sensitive on bowel ultrasound, thus potentially leading to more definitive treatment. Currently, there is no good study evaluating whether the use of bowel ultrasound affects clinical outcomes in VLBW patients over the use of abdominal radiography alone.

The use bowel ultrasound has yet to be adopted in the setting of suspicion for NEC at our institution. This is primarily due to the lack of expertise of the ultrasound technologists, radiologists and clinicians. With literature dating back to 2005 supporting the use of bowel ultrasound in diagnosis of severity of NEC, we would like to see if a regimen involving combined ultrasound and radiograph screening for NEC would make a difference in clinical outcomes (morbidity, mortality, and length of stay (LOS)) compared with radiograph screening alone.

Calprotectin is a protein found in the stool that, at elevated levels, indicates gastrointestinal inflammation. The addition of fecal biomarkers to the diagnostic work up for NEC also has promising impact. It has been suggested that fecal calprotectin levels obtained at the time of suspicion of NEC may be a useful noninvasive indicator to determine the severity of inflammation in the intestine and whether it is related to NEC or other forms of inflammation. Correlation of the fecal biomarkers with findings on BUS may be helpful to more definitively diagnose NEC.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Neonates born prior to or at 28 weeks gestation admitted to NICU at CMH

Exclusion Criteria:

  • Infants with chromosomal or multiple congenital anomalies
  • Unable to ultrasound the bowel (e.g. gut in silo, omphalocele, gastroschisis)
  • Infants who are greater than 36 corrected weeks upon admission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Arm A: AXR Only
Infants randomized to Arm A will obtain an abdominal x-ray (AXR) as per standard of care
Active Comparator: Arm B: AXR + Bowel US
Infants randomized to Arm B will obtain an abdominal x-ray (AXR) as per standard of care and a bowel ultrasound (BUS) as the intervention
Ultrasound imaging of the bowel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Requiring Medical Management
Time Frame: First 12 months

Evaluate the difference between medical and surgical management between study arms.

Medical management is defined as subjects whom did not undergo surgery for their NEC diagnosis.

Surgical management is defined as subjects that had a surgical intervention for the NEC diagnosis.

Please note that the study was terminated due to low enrollment numbers, thus statistically relevant and applicable numbers cannot be generated from this small study sample.

First 12 months
Number of Days Between NEC Diagnosis and Surgical Intervention
Time Frame: 12 months

The number of days between NEC diagnosis and surgical intervention for those that need it. Days were continuously counted until subject was discharged from the hospital.

Please note that the study was terminated due to low enrollment numbers, thus statistically relevant and applicable numbers cannot be generated from this small study sample.

12 months
Number of NPO Days
Time Frame: 12 months

Number of nothing by mouth (NPO) days between subject diagnosis of NEC to when subject was placed back on continuous feeds.

Please note that the study was terminated due to low enrollment numbers, thus statistically relevant and applicable numbers cannot be generated from this small study sample.

12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Erin Opfer, DO, Children's Mercy Hospital Kansas City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2018

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

December 19, 2018

First Submitted That Met QC Criteria

May 22, 2019

First Posted (Actual)

May 24, 2019

Study Record Updates

Last Update Posted (Actual)

January 10, 2022

Last Update Submitted That Met QC Criteria

January 6, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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