NEC Screening Abdominal Radiograph vs Bowel Ultrasound in Preemies

Premature Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03963011
• Other study ID #: 17030157
• Status: Terminated
• Phase: N/A
• Start date: December 20, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: December 2021
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Premature Birth
• Premature Infant

Intervention

Diagnostic Test:
• Bowel Ultrasound
Ultrasound imaging of the bowel

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 (7)

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;191(1):190-7. doi: 10.2214/AJR.07.3558. Erratum in: AJR Am J Roentgenol. 2008 Sep;191(3):931. — View Citation

Coursey CA, Hollingsworth CL, Wriston C, Beam C, Rice H, Bisset G 3rd. Radiographic predictors of disease severity in neonates and infants with necrotizing enterocolitis. AJR Am J Roentgenol. 2009 Nov;193(5):1408-13. doi: 10.2214/AJR.08.2306. — 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

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

Nakayuenyongsuk W, Christofferson M, Stevenson DK, Sylvester K, Lee HC, Park KT. Point-of-Care Fecal Calprotectin Monitoring in Preterm Infants at Risk for Necrotizing Enterocolitis. J Pediatr. 2018 May;196:98-103.e1. doi: 10.1016/j.jpeds.2017.12.069. Epub 2018 Mar 6. — 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Requiring Medical Management	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
Primary	Number of Days Between NEC Diagnosis and Surgical Intervention	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
Primary	Number of NPO Days	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