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

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ClinicalTrials.gov Identifier: NCT03142685
Recruitment Status : Withdrawn
First Posted : May 5, 2017
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Sherwin Chan, Children's Mercy Hospital Kansas City

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Enterocolitis, Necrotizing Congenital Heart Disease Device: Bowel Ultrasound Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a prospective pilot randomized control study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Randomized Control Trial of Necrotizing Enterocolitis Screening Using Abdominal Radiograph Versus Bowel Ultrasound Plus Abdominal Radiograph in Congenital Heart Disease Patients
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03142685


Locations
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United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
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Principal Investigator: Sherwin S Chan, MD PhD Children's Mercy Hospital Kansas City

Publications of Results:

Other Publications:
M. Epelman, A. Daneman, D. Podeberesky, L. Averill, K. Darge, paper presented at the Radiological Society of North America, Chicago, 2015.

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Responsible Party: Sherwin Chan, Pediatric Radiologist, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT03142685     History of Changes
Other Study ID Numbers: 16010050
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Sherwin Chan, Children's Mercy Hospital Kansas City:
NEC
Bowel Ultrasound
CHD

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Congenital Abnormalities
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Enterocolitis
Enterocolitis, Necrotizing
Cardiovascular Abnormalities
Gastroenteritis