Clinical Use of a Neonatal MRI System

The purpose of the present study is to continue clinical scanning on the NICU MRI with improved administrative processes and procedures, thereby making medically indicated, state of the art/high end MRI exams available to all infants treated at CCHMC.

Study Overview

Status

Completed

Conditions

Detailed Description

There are significant safety and image quality issues associated with transferring neonates from the Neonatal Intensive Care Unit (NICU) to the main Radiology Department for imaging in an adult-sized magnetic resonance imaging (MRI) scanner. For these reasons, the smallest and/or sickest neonates are typically precluded from receiving an MRI exam. The goal of our research effort is to bring high-performance MRI into the NICU so that all neonates can benefit from the same quality of diagnostic imaging as adults. To accomplish this, we have converted a commercial small-bore 1.5 Tesla (T) MRI scanner designed for orthopedic use into a neonatal MRI system optimized for whole body imaging of neonates (NICU MRI). To expand the imaging capabilities of the NICU MRI system, the measurement control electronics and operating system software of the FDA cleared OPTIMA platform have been augmented with state of the art HDX electronics and software currently used on a conventional commercially available adult sized whole body MRI scanner. The clinical safety of the integrated HDX/OPTIMA NICU MRI system and its ability to produce diagnostic image quality has been shown in 15 pilot patients (CCHMC Protocol 2011-2045). Further we have scanned almost 600 patients under a prior protocol (CCHMC Protocol 2011-2850) without an adverse event.

The present protocol seeks to allow continued performance of clinical MRI exams on the NICU magnet with improved administrative processes and procedures. NICU patients for whom an MRI exam is medically indicated will be recruited for the present study. Images will be obtained using both the FDA cleared OPTIMA NICU MRI platform and the integrated HDX/OPTIMA NICU MRI platform with the additional HDX images augmenting the OPTIMA images and contributing to diagnosis and guidance of subsequent clinical management. The specific MR imaging methods/procedures utilized will be determined by the type of exam to be performed and the medical indication. All of the MR images obtained will be reviewed by a board certified pediatric radiologist as part of clinical care and a clinical report will be generated and included in the infant's medical record.

Study Type

Interventional

Enrollment (Actual)

386

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • NICU, Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Any infant admitted to CCHMC
  • Have a medical condition for which an MRI exam is indicated, as determined by the attending neonatologist

Exclusion Criteria:

  • Infants too large to fit in the customized NICU MRI system comfortably (generally infants > 6 kg)
  • Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI for Neonates
MRI
MRI scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events as Observed During and After Scanning.
Time Frame: Day 1
Any observed physical changes will be recorded during and after scanning
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Each Infant's Baseline Measurement for Weight Will be Recorded.
Time Frame: Day 1
These measures will be used in order to facilitate future design of coils and transport tables for the customized MRI system.
Day 1
Each Infant's Anatomy Scanned Will be Obtained.
Time Frame: Day 1
The anatomy used will be used in order to facilitate understand the need for specific coils for the customized MRI system.
Day 1
Baseline Measurement for Days Old Will be Recorded.
Time Frame: Day 1
These measures will be used in conjunction with the weight at the time of scan to facilitate future design of coils and transport tables for the customized MRI system.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Beth M Kline-Fath, MD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2018

Primary Completion (Actual)

June 3, 2022

Study Completion (Actual)

September 9, 2022

Study Registration Dates

First Submitted

March 19, 2018

First Submitted That Met QC Criteria

March 19, 2018

First Posted (Actual)

March 26, 2018

Study Record Updates

Last Update Posted (Actual)

February 13, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CIN_NICUclinicalMRI_003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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