Image Evaluation
Conditions
Keywords
Neonate, Infant
Brief summary
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
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.
Interventions
Eligible subjects will undergo neonatal MRI scanning procedures.
Sponsors
Wellcome Trust
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Years
Healthy volunteers
No
Inclusion criteria
Subjects will be included that are: 1. Currently admitted for treatment or observation at the investigational site at the time of enrollment; 2. In the weight range less than 5.0 kg (\<5.0 kg ) and more than 0.5 kg (\>0.5 kg ); 3. Viable neonates (birth to 1 month of age) or infants (\>1 month to two years of age); 4. Able to safely undergo an MRI scan, as determined by the site's co-investigator neonatologist or medically qualified delegate; 5. Have parent(s), guardian(s), or legally authorized representative(s) willing and able to provide written informed consent for the subject's participation; 6. 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: 1. Maximum width (shoulder-to-shoulder measurement) less than eighteen (18 cm). 2. Maximum length (head-to-foot measurement) less than sixty (60) cm. -
Exclusion criteria
* Subjects will be excluded that: 1. 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; 2. 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; 3. 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; 4. 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 5. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary Rates of Adverse Events | 1 Day | Safety will be assessed based on the number of Adverse Events. |
| Image Diagnostic Quality | 1 Day | Number of subject whose images were rated as Evaluable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MRI Scan Time | 1 Day | Duration of MRI scan time for each subject |
| Overall Experience With Neonatal MR Scanner Device Summary | 1 day | User survey results on a scale from 1 to 5, where 1 = strongly disagree and 5 = strongly agree. |
| Overall Image Quality | 1 day | Scores range from 1-Very Poor image quality to 5-Excellent image quality. |
| Subject Change in Temperature | 1 Day | Change in temperature (Celsius) per subject. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 3.0 T Neonatal Scanner All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner.
3.0 T Neonatal MRI Scanner: Eligible subjects will undergo neonatal MRI scanning procedures. | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | 3.0 T Neonatal Scanner | — |
|---|---|---|
| Age, Categorical <=18 years | 9 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 9 participants | — |
| Sex: Female, Male Female | 6 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 1 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Image Diagnostic Quality
Number of subject whose images were rated as Evaluable
Time frame: 1 Day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3.0 T Neonatal Scanner | Image Diagnostic Quality | 9 Participants |
Primary
Summary Rates of Adverse Events
Safety will be assessed based on the number of Adverse Events.
Time frame: 1 Day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3.0 T Neonatal Scanner | Summary Rates of Adverse Events | 1 number of occurrences |
Secondary
MRI Scan Time
Duration of MRI scan time for each subject
Time frame: 1 Day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3.0 T Neonatal Scanner | MRI Scan Time | 57 minutes | Standard Deviation 6.08 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| 3.0 T Neonatal Scanner | Overall Experience With Neonatal MR Scanner Device Summary | Would recommend to others | 3.44 score on a scale |
| 3.0 T Neonatal Scanner | Overall Experience With Neonatal MR Scanner Device Summary | Like to use frequently | 3.22 score on a scale |
| 3.0 T Neonatal Scanner | Overall Experience With Neonatal MR Scanner Device Summary | Unnecessarily complex | 3.11 score on a scale |
| 3.0 T Neonatal Scanner | Overall Experience With Neonatal MR Scanner Device Summary | Easy to Use | 2.56 score on a scale |
| 3.0 T Neonatal Scanner | Overall Experience With Neonatal MR Scanner Device Summary | Would need tech support to use | 3.00 score on a scale |
| 3.0 T Neonatal Scanner | Overall Experience With Neonatal MR Scanner Device Summary | Functions are well integrated | 2.89 score on a scale |
| 3.0 T Neonatal Scanner | Overall Experience With Neonatal MR Scanner Device Summary | Too much inconsistency | 2.78 score on a scale |
| 3.0 T Neonatal Scanner | Overall Experience With Neonatal MR Scanner Device Summary | Most people would learn quickly | 3.00 score on a scale |
| 3.0 T Neonatal Scanner | Overall Experience With Neonatal MR Scanner Device Summary | Cumbersome to use | 3.0 score on a scale |
| 3.0 T Neonatal Scanner | Overall Experience With Neonatal MR Scanner Device Summary | Felt confident using | 3.0 score on a scale |
| 3.0 T Neonatal Scanner | Overall Experience With Neonatal MR Scanner Device Summary | Needed to learn a lot before using | 3.22 score on a scale |
| 3.0 T Neonatal Scanner | Overall Experience With Neonatal MR Scanner Device Summary | System meets patients needs | 3.56 score on a scale |
Secondary
Overall Image Quality
Scores range from 1-Very Poor image quality to 5-Excellent image quality.
Time frame: 1 day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3.0 T Neonatal Scanner | Overall Image Quality | 1-Very Poor | 0 Frequency of ratings |
| 3.0 T Neonatal Scanner | Overall Image Quality | 2-Poor | 0 Frequency of ratings |
| 3.0 T Neonatal Scanner | Overall Image Quality | 3-Neutral | 3 Frequency of ratings |
| 3.0 T Neonatal Scanner | Overall Image Quality | 4-Good | 6 Frequency of ratings |
| 3.0 T Neonatal Scanner | Overall Image Quality | 5-Excellent | 0 Frequency of ratings |
Secondary
Subject Change in Temperature
Change in temperature (Celsius) per subject.
Time frame: 1 Day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3.0 T Neonatal Scanner | Subject Change in Temperature | -0.07 Degrees Celsius | Standard Deviation 0.23 |