Utility of Bowel Ultrasound in Diagnosing Necrotizing Eneterocolitis in Congenital Heart Disease

July 16, 2018 updated by: Sherwin Chan, Children's Mercy Hospital Kansas City

Pilot Randomized Control Trial of Necrotizing Enterocolitis Screening Using Abdominal Radiograph Versus Bowel Ultrasound Plus Abdominal Radiograph in Congenital Heart Disease Patients

To evaluate the feasibility of performing a randomized pilot control trial of two diagnostic screening strategies for necrotizing enterocolitis in patients with congenital heart disease. Measures to evaluate will be the ability to obtain consent from patients, percentage of eligible patients that are able to be recruited, coordination of providers, estimation of degree of crossover and ability to perform the screening exams per protocol.

Study Overview

Status

Withdrawn

Conditions

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 and ICU stays.

Studies have shown that full-term neonates with congenital heart disease (CHD) are 3.7 to 6.3 times as likely to develop NEC compared with other premature neonates. The overall incidence of CHD is up to 12-14 per 1,000 live births and the incidence of NEC in patients with severe CHD is up to 10%. Patients with CHD have diastolic hypoperfusion causing inadequate blood circulation which can increase their risk of developing NEC. Treatment of NEC is often dependent on the clinical severity of the patient. Conservative treatment can be done in early stages of suspicion of NEC, while more severe NEC requires resection of the necrotic bowel. The current standard of care for diagnosis of NEC is based upon clinical suspicion, laboratory values and imaging characteristics found on an abdominal radiograph. Clinicians use the Modified Bells Staging Criteria (Appendix A) to diagnose patients with suspected NEC. Clinical manifestations often include abdominal bloating, feeding intolerance, constipation, emesis, ileus, and/or occult or frank blood in stool.

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) 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 patients with CHD 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, a high volume of CHD patients at our institution as well as new radiologists trained in bowel ultrasound, 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.

Study Type

Interventional

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

  • United States
    • 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 6 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients age 0-6 months with CHD
  • Completed one or more cardiac surgeries for CHD
  • Clinicians are suspicious for NEC and order an abdominal radiograph for screening.

Exclusion Criteria:

  • Patients with isolated PDA or PFO congenital cardiac abnormalities
  • Unable to ultrasound the bowel (eg. gut in silo)
  • Prior heart transplant

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm B: Kub + Bowel US
Subjects clinical suspected of NEC whom are randomized into Arm B at time of consent will receive a bowel ultrasound q24 for 48 hours and a KUB q12 for 48 hours.
Device: Bowel Ultrasound
Subjects randomized to Arm B will undergo a bowel ultrasound q24 for 48 hours after time of clinical suspicion of NEC. This is in addition to the standard of care KUBs which patients in both arms will get.
NO_INTERVENTION: Arm A: KUB Only
Subjects clinical suspected of NEC whom are randomized into Arm A at time of consent will receive a KUB q12 for 48 hours. This is the current standard-of-care procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days NPO due to NEC concern
Time Frame: From the date of enrollment to the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 500 days.
The number of days that a patient has no enteral feedings due to concern for necrotizing enterocolitis.
From the date of enrollment to the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 500 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU length of stay
Time Frame: From the date of enrollment to the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 500 days.
Days in the ICU during the current hospitalization
From the date of enrollment to the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 500 days.
Hospital length of stay
Time Frame: From the date of enrollment to the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 500 days.
Days in the hospital during the current hospitalization
From the date of enrollment to the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 500 days.

Collaborators and Investigators

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

Sponsor

Children's Mercy Hospital Kansas City

Investigators

  • Principal Investigator: Sherwin S Chan, MD PhD, 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)

January 1, 2017

Primary Completion (ACTUAL)

December 31, 2017

Study Completion (ACTUAL)

June 30, 2018

Study Registration Dates

First Submitted

April 26, 2017

First Submitted That Met QC Criteria

May 4, 2017

First Posted (ACTUAL)

May 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16010050

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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