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Diagnostic Test

Diagnostic Tools for Necrotizing Enterocolitis

N/A
Recruiting
Led By Sherwin Chan, MD, PhD
Research Sponsored by Children's Mercy Hospital Kansas City
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years
Awards & highlights

Summary

This trial will test if ultrasound is a useful tool in diagnosing NEC in premature babies in different NICUs.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves diagnostic procedures rather than medications, there are no direct side effects from drugs being tested. However, there may be discomfort or risks associated with handling preterm infants during BUS or exposure to radiation from abdominal radiographs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Impact of imaging algorithm on diagnostic thinking

Trial Design

2Treatment groups
Active Control
Group I: AXR Arm 1Active Control1 Intervention
Abdomen Radiograph
Group II: AXR + BUS Arm 2Active Control2 Interventions
Abdomen Radiograph + Bowel Ultrasound

Find a Location

Who is running the clinical trial?

Children's Mercy Hospital Kansas CityLead Sponsor
251 Previous Clinical Trials
930,280 Total Patients Enrolled
University of Kansas Medical CenterOTHER
488 Previous Clinical Trials
172,295 Total Patients Enrolled
American College of RadiologyOTHER
22 Previous Clinical Trials
8,054,086 Total Patients Enrolled

Media Library

Abdominal radiograph (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT05573113 — N/A
Necrotizing Enterocolitis Research Study Groups: AXR Arm 1, AXR + BUS Arm 2
Necrotizing Enterocolitis Clinical Trial 2023: Abdominal radiograph Highlights & Side Effects. Trial Name: NCT05573113 — N/A
Abdominal radiograph (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05573113 — N/A
~65 spots leftby Dec 2025
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