This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for imaging viable neonate and infant populations. This MR system has a smaller size and design features that may make it more feasible to locate the system in close proximity to care areas for neonates (birth - 1 month) and infants (less than 1 month to two years), such as clinical neonatal intensive care units (NICUs) and other infant and neonatal care departments.
This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for imaging viable neonate and infant populations. This MR system has a smaller size and design features that may make it more feasible to locate the system in close proximity to care areas for neonates (birth - 1 month) and infants (\>1 month to two years), such as clinical neonatal intensive care units (NICUs) and other infant and neonatal care departments. This is a two-phase prospective clinical study evaluating the performance and safety of the investigational MRI device for neonates and infants, including: * Phase 1 - Initial feasibility assessment and optimization study (Phase 1) which may include hardware and software modifications. These studies are guided by a series of MR scanning procedures defined in sequential Sponsor-provided MR Procedure Documents * Phase 2 - Controlled image and data collection study based on Phase 1 results, in which optimized scan procedure(s) according to MR Procedure Document(s) will be provided at the start of Phase 2 scanning and a fixed hardware and integrated software configuration will be applied for all subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
9
Eligible subjects will undergo neonatal MRI scanning procedures.
Boston Children's Hospital
Boston, Massachusetts, United States
Summary Rates of Adverse Events
Safety will be assessed based on the number of Adverse Events.
Time frame: 1 Day
Image Diagnostic Quality
Number of subject whose images were rated as Evaluable
Time frame: 1 Day
MRI Scan Time
Duration of MRI scan time for each subject
Time frame: 1 Day
Overall Experience With Neonatal MR Scanner Device Summary
User survey results on a scale from 1 to 5, where 1 = strongly disagree and 5 = strongly agree.
Time frame: 1 day
Overall Image Quality
Scores range from 1-Very Poor image quality to 5-Excellent image quality.
Time frame: 1 day
Subject Change in Temperature
Change in temperature (Celsius) per subject.
Time frame: 1 Day
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