Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Development of MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit

Conditions
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Image Evaluation

Intervention / Treatment
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* Device: 3.0 T Neonatal MRI Scanner


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects will be included that are: Currently admitted for treatment or observation at the investigational site at the time of enrollment; In the weight range less than 5.0 kg (<5.0 kg ) and more than 0.5 kg (>0.5 kg ); Viable neonates (birth to 1 month of age) or infants (>1 month to two years of age); Able to safely undergo an MRI scan, as determined by the site's co-investigator neonatologist or medically qualified delegate; Have parent(s), guardian(s), or legally authorized representative(s) willing and able to provide written informed consent for the subject's participation; Are of appropriate size and shape to fit into the bore of the magnet, inclusive of all monitoring equipment, if any, necessary for the subject's routine clinical care: Maximum width (shoulder-to-shoulder measurement) less than eighteen (18 cm). Maximum length (head-to-foot measurement) less than sixty (60) cm. - Exclusion Criteria: Subjects will be excluded that: Have parent(s), guardian(s), or legally authorized representative(s) that require that they accompany the subject into the MR environment that have contraindications to the MR environment or would otherwise be put at undue risk or discomfort, as determined by the investigators; Require any non-removable medical devices that are not compatible with MR scanning (labeled as MR Unsafe, MR condition for which the scanning conditions are not met, or no MR safety labeling) that may pose hazards in the MR scanning or MR environment, in the opinion of the neonatologist co-investigator or medically qualified delegate; Have other contraindications or could otherwise be expected to experience detrimental effects to safety, well-being, or medical care, as determined by the neonatologist co-investigator; Require any scheduled standard of care procedures that are expected to be adversely impacted by participation in this study, in the opinion of the principal investigator, neonatologist co-investigator, or medically qualified delegate; and Have been previously enrolled AND undergone any study procedures under the current study protocol (i.e. the same subject cannot undergo study procedures, including swaddling and/or MR scanning, more than once).

Ages Eligible for Study
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Maximum Age: 2 Years

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 3.0 T Neonatal Scanner<br>All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. | Device: 3.0 T Neonatal MRI Scanner<br>* Eligible subjects will undergo neonatal MRI scanning procedures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary Rates of Adverse Events | Safety will be assessed based on the number of Adverse Events. | 1 Day | 
| Image Diagnostic Quality | Number of subject whose images were rated as Evaluable | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI Scan Time | Duration of MRI scan time for each subject | 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. | 1 day | 
| Overall Image Quality | Scores range from 1-Very Poor image quality to 5-Excellent image quality. | 1 day | 
| Subject Change in Temperature | Change in temperature (Celsius) per subject. | 1 Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant, Neonate