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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03142685
• Other study ID #: 16010050
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2018
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Enterocolitis
• Enterocolitis, Necrotizing
• Heart Defects, Congenital
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

References & Publications (12)

Becker KC, Hornik CP, Cotten CM, Clark RH, Hill KD, Smith PB, Lenfestey RW. Necrotizing enterocolitis in infants with ductal-dependent congenital heart disease. Am J Perinatol. 2015 Jun;32(7):633-8. doi: 10.1055/s-0034-1390349. Epub 2014 Dec 8. — View Citation

Coursey CA, Hollingsworth CL, Gaca AM, Maxfield C, Delong D, Bisset G 3rd. Radiologists' agreement when using a 10-point scale to report abdominal radiographic findings of necrotizing enterocolitis in neonates and infants. AJR Am J Roentgenol. 2008 Jul;19 — View Citation

Epelman M, Daneman A, Navarro OM, Morag I, Moore AM, Kim JH, Faingold R, Taylor G, Gerstle JT. Necrotizing enterocolitis: review of state-of-the-art imaging findings with pathologic correlation. Radiographics. 2007 Mar-Apr;27(2):285-305. Review. — View Citation

Faingold R, Daneman A, Tomlinson G, Babyn PS, Manson DE, Mohanta A, Moore AM, Hellmann J, Smith C, Gerstle T, Kim JH. Necrotizing enterocolitis: assessment of bowel viability with color doppler US. Radiology. 2005 May;235(2):587-94. — View Citation

Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol. 2002 Jun 19;39(12):1890-900. Review. — View Citation

Kim WY, Kim WS, Kim IO, Kwon TH, Chang W, Lee EK. Sonographic evaluation of neonates with early-stage necrotizing enterocolitis. Pediatr Radiol. 2005 Nov;35(11):1056-61. Epub 2005 Aug 3. — View Citation

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

McElhinney DB, Hedrick HL, Bush DM, Pereira GR, Stafford PW, Gaynor JW, Spray TL, Wernovsky G. Necrotizing enterocolitis in neonates with congenital heart disease: risk factors and outcomes. Pediatrics. 2000 Nov;106(5):1080-7. — View Citation

Motta C, Scott W, Mahony L, Koch J, Wyckoff M, Reisch J, Burchfield PJ, Brion LP. The association of congenital heart disease with necrotizing enterocolitis in preterm infants: a birth cohort study. J Perinatol. 2015 Nov;35(11):949-53. doi: 10.1038/jp.201 — View Citation

Pickard SS, Feinstein JA, Popat RA, Huang L, Dutta S. Short- and long-term outcomes of necrotizing enterocolitis in infants with congenital heart disease. Pediatrics. 2009 May;123(5):e901-6. doi: 10.1542/peds.2008-3216. — View Citation

Staryszak J, Stopa J, Kucharska-Miasik I, Osuchowska M, Guz W, Blaz W. Usefulness of ultrasound examinations in the diagnostics of necrotizing enterocolitis. Pol J Radiol. 2015 Jan 1;80:1-9. doi: 10.12659/PJR.890539. eCollection 2015. — View Citation

Walsh MC, Kliegman RM. Necrotizing enterocolitis: treatment based on staging criteria. Pediatr Clin North Am. 1986 Feb;33(1):179-201. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days NPO due to NEC concern	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	ICU length of stay	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.
Secondary	Hospital length of stay	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.