Diagnostic Tools for Necrotizing Enterocolitis

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

182 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Abdominal radiograph and Bowel Ultrasound for diagnosing necrotizing enterocolitis?

Research suggests that using bowel ultrasound alongside abdominal radiographs can improve the early diagnosis of necrotizing enterocolitis by providing more detailed information about the bowel's condition, such as its thickness and blood flow, which are not visible on standard X-rays. ^{1 2 3 4 5}

Is it safe to use bowel ultrasound and abdominal radiograph for diagnosing necrotizing enterocolitis in infants?

The studies suggest that using bowel ultrasound and abdominal radiograph together is feasible and acceptable for diagnosing necrotizing enterocolitis in infants, with no significant safety concerns reported. ^{2 3 6 7 8}

How does the treatment using abdominal radiograph and bowel ultrasound differ from other treatments for necrotizing enterocolitis?

This treatment is unique because it uses ultrasound to provide a detailed view of the bowel, which can help identify necrosis (tissue death) more accurately than traditional X-rays, and it avoids exposing newborns to radiation. While X-rays are the standard, ultrasound offers a promising alternative that is not yet widely adopted in routine care. ^{4 9 10 11 12}

Research Team

Sherwin Chan, MD PhD

Principal Investigator

Children's Mercy Kansas City

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Germany pubmed.ncbi.nlm.nih.gov

The role of ultrasound in necrotizing enterocolitis. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Does abdominal sonography provide additional information over abdominal plain radiography for diagnosis of necrotizing enterocolitis in neonates? [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Bedside Ultrasound for Early Diagnosis of Necrotizing Enterocolitis: A Pilot Study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Role of Abdominal US in Diagnosis of NEC. [2019]

5. Poland pubmed.ncbi.nlm.nih.gov

Usefulness of ultrasound examinations in the diagnostics of necrotizing enterocolitis. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a diagnostic randomized clinical trial of bowel ultrasound in infants with suspected necrotizing enterocolitis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Utilizing ultrasound in suspected necrotizing enterocolitis with equivocal radiographic findings. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Abdominal ultrasound findings contribute to a multivariable predictive risk score for surgical necrotizing enterocolitis: A pilot study. [2021]

9. Pakistan pubmed.ncbi.nlm.nih.gov

Diagnostic value and disease evaluation significance of abdominal ultrasound inspection for neonatal necrotizing enterocolitis. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Sonographic and radiographic imaging features of the neonate with necrotizing enterocolitis: correlating findings with outcomes. [2022]

11. China pubmed.ncbi.nlm.nih.gov

[Value of abdominal ultrasound in the diagnosis of neonatal necrotizing enterocolitis and evaluation of disease severity]. [2020]

12. Poland pubmed.ncbi.nlm.nih.gov

[Ultrasound examination in diagnosis and monitoring of necrotizing enterocolitis in a group of newborns with birth weight below 2000 g--a preliminary report]. [2019]