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Utility of Bowel Ultrasound in Diagnosing Necrotizing Eneterocolitis in Congenital Heart Disease

NCT03142685 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-07-18

No results posted yet for this study

Summary

To evaluate the feasibility of performing a randomized pilot control trial of two diagnostic screening strategies for necrotizing enterocolitis in patients with congenital heart disease. Measures to evaluate will be the ability to obtain consent from patients, percentage of eligible patients that are able to be recruited, coordination of providers, estimation of degree of crossover and ability to perform the screening exams per protocol.

Conditions

  • Enterocolitis, Necrotizing
  • Congenital Heart Disease

Interventions

DEVICE

Bowel Ultrasound

Subjects randomized to Arm B will undergo a bowel ultrasound q24 for 48 hours after time of clinical suspicion of NEC. This is in addition to the standard of care KUBs which patients in both arms will get.

Sponsors & Collaborators

  • Children's Mercy Hospital Kansas City

    lead OTHER

Principal Investigators

  • Sherwin S Chan, MD PhD · Children's Mercy Hospital Kansas City

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2017-12-31
Completion
2018-06-30
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 NCT03142685 on ClinicalTrials.gov