Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis

Status Recruiting

Clinical Trial Summary

The overall objective of our study is to determine the clinical usefulness of BUS for NEC evaluation in diverse NICU settings.

Clinical Trial Description

Bowel ultrasound (BUS) for NEC evaluation is a non-invasive imaging modality that allows real-time assessment of the intestinal wall, vascular perfusion, peristalsis, and abdominal fluid. Advantages of BUS is it is non-invasive, does not have radiation, does not require special preparation before procedure, and is well tolerated even by sick preterm infants. BUS is already being used in centers that have sufficient BUS expertise as an alternative standard of care approach for evaluating NEC, but in a highly variable manner. Standard ultrasound equipment is all that is needed for BUS. Pre-study training will be conducted for sonographers to acquire the study BUS images using standardized technique. Pre-study training of radiologists will also be conducted to standardize the interpretation of BUS findings for NEC. All BUS for NEC ordering, acquisition, and interpretation in the study will be the same as the standard workflow for any other imaging ordered in the clinical setting. All BUS performed as part of the study will not be charged to patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05573113
Study type	Interventional
Source	Children's Mercy Hospital Kansas City
Contact	Maura Sien, MS, RT(R)
Phone	18163026065
Email	mesien@cmh.edu
Status	Recruiting
Phase	N/A
Start date	November 1, 2022
Completion date	December 31, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05544097` - Spectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis	N/A
Recruiting	`NCT03210831` - Early Predictors of Necrotizing Enterocolitis in Neonates
Not yet recruiting	`NCT06045130` - PUFAs in Preterm Infants
Recruiting	`NCT02552706` - The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis	N/A
Completed	`NCT02400697` - Placental Transfusion Project for Preterm Infants	N/A
Completed	`NCT01751477` - Infloran® for Prevention of Necrotizing Enterocolitis	N/A
Terminated	`NCT01156480` - Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants	N/A
Completed	`NCT00787124` - Transfusions and Nitric Oxide Level in Preterm Infants
Unknown status	`NCT00254176` - Cysteine Supplementation in Critically Ill Neonates	Phase 2/Phase 3
Recruiting	`NCT01441739` - Intestinal Failure in Necrotising Enterocolitis	N/A
Recruiting	`NCT04074824` - A Genome-Wide Association Study for Neonatal Diseases
Recruiting	`NCT03869827` - Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction
Terminated	`NCT03320785` - Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation
Active, not recruiting	`NCT03554278` - Alteration of Stool Microbiota in Preterm Infants With Anemia
Not yet recruiting	`NCT04541771` - The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants	Phase 2
Not yet recruiting	`NCT03700957` - The Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates	N/A
Completed	`NCT03551600` - Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
Completed	`NCT01745510` - Enteral Administration of Docosahexaenoic Acid to Prevent Necrotizing Enterocolitis in Preterm Neonates	Phase 1/Phase 2
Unknown status	`NCT01807858` - The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants	N/A
Completed	`NCT01735578` - Splanchnic Tissue Oxygenation During Enteral Feedings in Anemic Premature Infants at Risk for Necrotizing Enterocolitis	N/A