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OpenTrials
Completed

NCT Number: NCT01801865

Clinical Use of a New Neonatal MRI System

The purpose of the present study is to make medically indicated state of the art/high end magnetic resonance imaging (MRI) exams available to all infants in the Cincinnati Children's Hospital Medical Center (CCHMC) Neonatal Intensive Care Unit (NICU).

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NICU, Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

The current practice of transferring infants from the Neonatal Intensive Care Unit (NICU) to radiology departments and imaging in adult-sized magnetic resonance imaging (MRI) scanners is associated with significant safety and image quality issues. For these reasons, the smallest and/or sickest neonates are typically precluded from receiving an MRI exam. The overreaching 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. To expand the imaging capabilities of the NICU MRI system, the measurement control electronics and operating system software of the FDA cleared imaging 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). The present protocol builds and expands upon the previous to use the integrated NICU MRI system to perform MRI exams in the neonatal population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any infant admitted to the NICU at CCHMC
  • Have a medical condition for which an MRI exam is indicated, as determined by the attending neonatologist
  • Able to maintain body temperature for at least 90 minutes without the aid of an incubator or radiant warmer int he opinion of the attending neonatologist
  • Parental/LAR permission obtained

Exclusion criteria

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

Treatment and study plan

GE OPTIMA MR430s with HDx/GE Electronics

Device

Other names: GE OPTIMA 1.5T MRI

Primary outcomes

  1. Number of Participants With Adverse Events as Observed During and After Scanning.

    Time frame: Day 1

    Any observed physical changes either related or not related to the MRI was recorded during and after scanning.

Secondary outcomes

  1. Each Infant's Baseline Measurement for Weight Will be Recorded to Ensure the Infant is Less Than 6 kg.

    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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Mar 1, 2013
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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