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NEC Screening Abdominal Radiograph vs Bowel Ultrasound in Preemies

NCT03963011 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-01-10

Study results available
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Summary

The overall primary objective is to establish the feasibility and pilot the design and delivery of a diagnostic randomized controlled trial (RCT) of BUS (bowel ultrasound) for NEC evaluation which will lead to a successful application for a larger, multi-center clinical trial in the future. This program of research is anticipated to have a significant positive impact in the timely and accurate diagnosis of NEC in preterm infants.

Conditions

  • Enterocolitis, Necrotizing
  • Premature Infant

Interventions

DIAGNOSTIC_TEST

Bowel Ultrasound

Ultrasound imaging of the bowel

Sponsors & Collaborators

  • Children's Mercy Hospital Kansas City

    lead OTHER

Principal Investigators

  • Erin Opfer, DO · Children's Mercy Hospital Kansas City

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
28 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-20
Primary Completion
2020-10-01
Completion
2020-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03963011 on ClinicalTrials.gov