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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Children's Mercy Hospital Kansas CityLead Sponsor

245 Previous Clinical Trials

935,639 Total Patients Enrolled

University of Kansas Medical CenterOTHER

464 Previous Clinical Trials

169,115 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum capacity of participants for this research project?

"Confirmed. Data hosted on clinicaltrials.gov reveals that this medical trial, posted on November 1st 2022, is currently recruiting patients from one location. The research team aims to enrol 160 participants in total."

Answered by AI

Are there still vacancies to participate in this investigation?

"The information on clinicaltrials.gov demonstrates that this medical investigation is in its recruitment phase, with the initial listing posted on November 1st 2022 and the latest update being December 5th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis

Sherwin Chan MD PhD 2022. "Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05573113.

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