Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

NEC Screening Abdominal Radiograph vs Bowel Ultrasound in Preemies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03963011
Recruitment Status : Recruiting
First Posted : May 24, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Mercy Hospital Kansas City

Brief 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.

Condition or disease Intervention/treatment Phase
Enterocolitis, Necrotizing Premature Infant Diagnostic Test: 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 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Infants randomized to the AXR only arm will obtain an AXR as per standard of care. Repeat AXR, if any, will be left to the discretion of the treating neonatologist. In this arm, no BUS study will be performed unless the attending neonatologist decides it is clinically indicated. This situation is expected to be exceedingly rare, as BUS is not part of the standard of care for NEC evaluation. Infants randomized to the AXR and BUS arm will also get an AXR, with repeat AXR left to the discretion of the treating neonatologist. In addition to this standard of care, infants randomized to this arm will receive a BUS as the intervention. This BUS will be ordered at the same time as the initial AXR and will be performed within six hours of the order being placed.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Randomized Control Trial of Necrotizing Enterocolitis Screening Abdominal Radiograph Versus Bowel Ultrasound Plus Abdominal Radiograph in Premature Neonates
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound X-Rays

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
Diagnostic Test: Bowel Ultrasound
Ultrasound imaging of the bowel




Primary Outcome Measures :
  1. Rates of medical versus surgical management [ Time Frame: First 12 months ]
    Evaluate the difference between medical and surgical management between study arms


Secondary Outcome Measures :
  1. Evaluate days between NEC diagnosis and surgical intervention [ Time Frame: Months 12-18 ]

    Compare the number of days between NEC diagnosis and surgical intervention between study arms

    1. The rates of medical versus surgical management
    2. The days between NEC diagnosis and surgical intervention for those that need it
    3. The days NPO for those that get medical management

  2. NPO Days [ Time Frame: Months 18-24 ]
    Compare the number of NPO days between medical and surgical patients

  3. Usefulness of Fecal Calprotectin [ Time Frame: Months 18-24 ]
    Evaluate the usefulness of serial fecal calprotectin levels as a predictive biomarker for NEC



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 28 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03963011


Contacts
Layout table for location contacts
Contact: Erin Payne, RN, BSN 816-302-3065 epayne@cmh.edu
Contact: Amie Robinson, BSRT(R)(MR), CCRP 8163028311 alrobinson@cmh.edu

Locations
Layout table for location information
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Amie Robinson    816-302-8311    alrobinson@cmh.edu   
Principal Investigator: Erin Opfer, DO         
Sub-Investigator: Sherwin Chan, MD, PhD         
Sub-Investigator: Alain Cuna, MD         
Sub-Investigator: Valentina Shaknovich, MD         
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Layout table for investigator information
Principal Investigator: Erin Opfer, DO Children's Mercy Hospital Kansas City

Publications:

Layout table for additonal information
Responsible Party: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT03963011     History of Changes
Other Study ID Numbers: 17030157
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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 Children's Mercy Hospital Kansas City:
NEC
Necrotizing Enterocolitis
Premature Infant
Calprotectin

Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Enterocolitis
Enterocolitis, Necrotizing
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases