Pilot Study: Safety of a Customized MRI System for Neonatal Imaging

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety of a customized MRI scanner and gather preliminary data on image quality in a group of 10 medically stable infants admitted to the Neonatal Intensive Care Unit (NICU) at Cincinnati Children's Hospital Medical Center (CCHMC).

Detailed Description
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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 potential of MRI for diagnosing disease in neonates has yet to be fully realized. The overreaching goal of our research effort is to bring high-performance MRI into the NICU so that 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. The purpose of this initial study is to determine the safety of the customized scanner installed in the NICU at Cincinnati Children's Hospital Medical Center (CCHMC) and gather preliminary data on image quality in a group of 10 medically stable infants admitted to the CCHMC NICU.

Official Title
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Pilot Study: Safety of a Customized MRI System for Neonatal Imaging

Conditions
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Safety of a Customized NICU MRI System

Intervention / Treatment
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* Device: GE OPTIMA MR430s with HDX/GE Electronics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any infant admitted to the NICU at CCHMC Medically stable as per the opinion of the attending neonatologist currently on service Parental consent obtained Exclusion Criteria: Infants too large to fit in the customized NICU MRI system comfortably (expected to be infants >4.5 kg) Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Safety of a Customized NICU MRI System<br>Device: GE OPTIMA MR430s with HDX/GE Electronics | Device: GE OPTIMA MR430s with HDX/GE Electronics<br>* MRI scan(s) for no longer than 60 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events as Measured by Vital Signs, Change in Temperature, and Physical Exam | Heart rate and oxygen saturation will be measured every 15+/- 5 minutes. The infants' temperatures will be taken immediately before the MRI and again immediately after the MRI. A physical exam will be performed both immediately before and immediately after the MRI to assess for any physical changes. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI Image Quality | The following measures will be individually evaluated and compared to similar images previously acquired on an adult scanner: Overall Study Quality, Motion, Spatial Resolution, Signal to Noise, and Contrast. | Post MRI Scan for Each Infant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NICU, MRI, Neonatal, Safety, Efficacy, Cincinnati