Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03963011
Study type Interventional
Source Children's Mercy Hospital Kansas City
Contact
Status Terminated
Phase N/A
Start date December 20, 2018
Completion date October 1, 2020

See also
  Status Clinical Trial Phase
Terminated NCT02550054 - Erythropoietin in Premature Infants to Prevent Encephalopathy Phase 2
Completed NCT03827252 - Respiratory Stability and Vegetative Coupling During Neonatal Skin-to-skin Care
Active, not recruiting NCT03345069 - Cincinnati Infant Neurodevelopment Early Prediction Study (CINEPS)
Completed NCT04067206 - The Effects Of Auditory Interventions On Pain And Comfort In Premature Infants N/A
Completed NCT03911674 - Effects of Oral Stimulation in Preterm Infants Phase 3
Completed NCT03324126 - Individualized Fortification of Breast Milk N/A
Completed NCT03704012 - Efficacy of Massage Applied by the Parents in Hospitalized Premature Birth (PreMas) N/A
Active, not recruiting NCT03241082 - Ultrasound Assessment of BC in the NICU
Completed NCT03701906 - Effect of a Mixture of New Probiotic Strains in Preterm Infants N/A
Completed NCT02133716 - Efficacy of Breast Milk Expressed and Sucrose in Procedural Pain in Preterm Phase 4
Not yet recruiting NCT05543005 - Efficacy Study of an Audio Device Outside Incubator Allowing Broadcasting Maternal Voice on Stability in Preterm Infants N/A
Recruiting NCT03852641 - Feeding Premature Infants During Non-invasive Respiratory Support N/A
Active, not recruiting NCT03423914 - Efficacy of Expressive Writing in Mothers of Preterm Infants N/A
Recruiting NCT04648787 - A Study of Family-integrated Care for Reducing Uncertainty N/A
Recruiting NCT04866342 - Servo Controlled Oxygen Targeting (SCO2T) Study: Masimo vs. Nellcor N/A
Not yet recruiting NCT02534090 - Evaluation of Feeding Intolerance in Premature Infants Using Near Infrared Spectroscopy N/A
Not yet recruiting NCT02601872 - Erythropoietin in Premature Infants to Prevent Encephalopathy Phase 2
Recruiting NCT06212427 - Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs) N/A
Suspended NCT03939169 - The Efficiency of Using Supportive Postures and Holding Techniques to Minimize Premature Infant Pain (PAP) N/A
Completed NCT03706586 - The Hilo Pilot -Trial to Assess Feasibility N/A