Diagnostic Tools for Necrotizing Enterocolitis

No longer recruiting at 1 trial location

Overseen By Sarah Foster, RT(R)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Mercy Hospital Kansas City

Disqualifiers: Gastroschisis, Omphalocele, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of two imaging methods for diagnosing necrotizing enterocolitis (NEC) in newborns. One group will receive an abdominal X-ray, while the other will undergo both an X-ray and a bowel ultrasound. The trial aims to determine which method performs better across different newborn intensive care units (NICUs). Babies in the NICU showing signs of NEC, who require further imaging as determined by their doctor, may be suitable candidates. As an unphased trial, this study provides an opportunity to contribute to important research that could enhance diagnostic methods for newborns.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these diagnostic tools are safe for evaluating NEC in NICU settings?

Research has shown that abdominal X-rays, often used to diagnose necrotizing enterocolitis (NEC), are generally safe. However, they involve radiation exposure, which requires consideration, especially if multiple X-rays are needed over time.

Bowel ultrasound (BUS) is another method under study for NEC. Studies have demonstrated that BUS is safe and does not use radiation. It can detect signs of NEC, such as bowel wall thickening and gas, before they appear on X-rays, making it a promising tool for early detection.

Both methods are commonly used in medical settings to diagnose conditions like NEC, and significant negative effects specifically related to these methods have not been reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores advanced diagnostic tools for necrotizing enterocolitis, a serious condition in newborns. Current standard methods often rely heavily on clinical signs and imaging like abdominal X-rays, which can sometimes miss early signs of the disease. This trial investigates whether combining abdominal radiographs with bowel ultrasounds offers a more precise and earlier diagnosis. By using ultrasound, which can provide real-time images and detailed views of bowel structure and blood flow, doctors aim to catch the condition sooner, potentially leading to faster and more effective interventions.

What evidence suggests that this trial's diagnostic tools could be effective for evaluating NEC?

Research shows that abdominal X-rays are commonly used to diagnose necrotizing enterocolitis (NEC), but they have limitations, especially for early detection. In this trial, participants will follow different diagnostic approaches. One group will use abdominal radiographs alone, while another will combine abdominal radiographs with bowel ultrasound (BUS). Studies suggest that BUS might be more effective for early NEC diagnosis. Specifically, one study found that BUS is highly accurate, with a sensitivity of 75% and a specificity of 97.6%. BUS has proven better than X-rays at identifying early signs of NEC, such as bowel wall thickening and gas in the portal vein. Overall, BUS may offer a more reliable tool for early NEC detection compared to traditional X-rays. ^{2 3 6 7 8}

Who Is on the Research Team?

Sherwin Chan, MD PhD

Principal Investigator

Children's Mercy Kansas City

Are You a Good Fit for This Trial?

This trial is for preterm infants born at or before 32 weeks' gestation, who are in the NICU at CMKC or KUMC and suspected of having Necrotizing Enterocolitis (NEC) needing further imaging. Infants with major gastrointestinal anomalies like gastroschisis or omphalocele that prevent bowel ultrasound (BUS) cannot participate.

Inclusion Criteria

My baby is in the NICU for possible NEC and needs more tests as decided by their doctor.

Exclusion Criteria

My infant cannot have a belly ultrasound due to major stomach issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-study Training

Pre-study training for sonographers and radiologists to standardize BUS image acquisition and interpretation

4 weeks

Treatment

Participants undergo either abdominal radiograph alone or abdominal radiograph plus bowel ultrasound for NEC evaluation

2 years

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Abdominal radiograph
• Bowel Ultrasound

Trial Overview The study aims to compare the effectiveness of two diagnostic methods for NEC: Bowel Ultrasound (BUS) versus Abdominal radiograph. It will assess which method is more useful in different NICU settings when evaluating NEC.

How Is the Trial Designed?

Group I: AXR Arm 1 Active Control 1 Intervention

Abdomen Radiograph

Group II: AXR + BUS Arm 2 Active Control 2 Interventions

Abdomen Radiograph + Bowel Ultrasound

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

University of Kansas Medical Center

Collaborator

Trials

527

Recruited

181,000+

American College of Radiology

Collaborator

Trials

24

Recruited

8,055,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6396957/

Abdominal Ultrasound and Abdominal Radiograph to ... Abdominal radiographs are the current standard for diagnosing NEC but have significant limitations in diagnosing early NEC.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03963011?cond=%22Enterocolitis,%20Necrotizing%22&viewType=Table&rank=8

NEC Screening Abdominal Radiograph vs Bowel ... Feasibility and acceptability of a diagnostic randomized clinical trial of bowel ultrasound in infants with suspected necrotizing enterocolitis. Eur J ...

3. scholarlyexchange.childrensmercy.org scholarlyexchange.childrensmercy.org/cgi/viewcontent.cgi?article=6088&context=papers

Imaging for Diagnosis and Assessment of Necrotizing ... Abdominal ultrasound and abdominal radiograph to diagnose necrotizing enterocolitis in extremely preterm infants. Kans J Med 2019;12(1):24–27. PMID: 30854167.

4. ajronline.org ajronline.org/doi/pdf/10.2214/ajr.154.4.2107676

Diagnostic quality of portable abdominal radiographs in ... This study was undertaken to deter- mine if the digital manipulation of a conventional radiographic image of the neonatal abdomen might increase the sensitivity.

5. qims.amegroups.org qims.amegroups.org/article/view/14480/html

Diagnostic imaging features of necrotizing enterocolitis Imaging modality in the diagnosis of NEC is historically represented by the plain-film abdominal radiographs which can be performed every 6 hours because of the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9976546/

Imaging for Diagnosis and Assessment of Necrotizing ... Plain abdominal radiographs can also have significant interobserver variability in NEC diagnosis, and the frequent need for multiple serial X-rays exposes ...

7. publications.aap.org publications.aap.org/pediatricsinreview/article/38/12/552/31953/Necrotizing-Enterocolitis

Necrotizing Enterocolitis | Pediatrics In Review An abdominal radiograph is often obtained for diagnosis, and findings that indicate NEC include pneumatosis and portal venous gas. The treatment ...

8. emedicine.medscape.com emedicine.medscape.com/article/977956-workup

Necrotizing Enterocolitis Workup Abdominal imaging studies are crucial at this stage. In fact, radiographic studies should be obtained if any concern about NEC is present.