Neonatal Neuroimaging
Conditions
Keywords
MRI Scanner, NICU
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 (\>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. Investigator feedback on scanning conducted under each MR Procedure Document will be documented. Because the device is intended for use in viable neonate and infant populations, clinical data are required that cannot be conducted in any other populations or simulated on non-human models. Clinical images and associated data as well as assessments of image quality, workflow, and usability will be collected. Images, associated image data, and subject data collected in both phases of this study may be used for future engineering development and activities that support MR product development, including Sponsor-authorized scientific and marketing activities. Summary evaluation of safety and performance from Phase 1 and Phase 2 may be used in support of regulatory submission, including filings for European CE mark.
Interventions
eligible subjects will undergo neonatal MRI scan procedure
Sponsors
Wellcome Trust
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 2 Years
Healthy volunteers
Yes
Inclusion criteria
* Currently admitted for treatment or observation at the investigational site at the time of enrolment; * 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 medically qualified personnel; * 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 based on standard of care measurement methods, in accordance with site policies : 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
* 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 medically qualified personnel; * Have any ferrous or electrical items or non-removable medical devices that are not compatible with MR scanning (including devices labelled as MR Unsafe, MR conditional for which the scanning conditions are not met, or without MR safety labelling that does not satisfy site MR safety requirements) that may pose hazards in the MR scanning or MR environment, in the opinion of the Principal Investigator or medically qualified personnel in accordance with the site's MR Safety policy; * Have any contraindications or could otherwise be expected to experience detrimental effects to safety, well-being, or medical care, as determined by the Principal Investigator or medically qualified personnel in accordance with the site's MR Safety policy; * 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 or medically qualified personnel; 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image Diagnostic Quality for Phase 1 | 1 Day | Number of subject whose images were rated as Evaluable. |
| Number of Participants Who Experienced an Adverse Event in Phase 1 | 1 Day | Safety will be assessed based on the number of Adverse Events in Phase 1. |
| Image Diagnostic Quality for Phase 2 | 1 Day | Number of subject whose images were rated as Evaluable. |
| Number of Participants Who Experienced an Adverse Event in Phase 2 | 1 Day | Safety will be assessed based on the number of Adverse Events in Phase 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bi-polar Product Description Scale | 1 Day | A measure of bi-polar items (opposite items), rated on a scale from 1 to 7. Closer to 1 indicates a measure closer to the first item and closer to 7 indicates a measure closer to the second item. |
| Summary of Image Quality and Assessment for Phase 1 | 1 Day | Scores range from 1-Very Poor image quality to 5-Excellent image quality. |
| Subject Change in Temperature | 1 Day | — |
| Technical Issues and Malfunctions | 1 Day | Number and type of technical issues and device malfunctions |
| Summary of Image Quality and Assessments for Phase 2 | 1 Day | Scores range from 1-Very Poor image quality to 5-Excellent image quality. |
| Per Subject Workflow and Transport Information | 1 Day | Summary of means and standard deviations. |
| Overall Experience With the 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. Question 1. I think that I would like to use this system frequently Question 2. I found the system unnecessarily complex Question 3. I thought the system was easy to use Question 4. I think that I would need support from a technician to be able to use this system Question 5. I found the various functions in this system were well integrated Question 6. I thought there was too much inconsistency in this system Question 7. I think that most people would learn to use this system very quickly Question 8. I found the system very cumbersome to use Question 9. I felt very confident using the system Question 10. I needed to learn a lot of things before I could get going with this system Question 11. I feel confident this system will meet my patient's needs Question 12. How likely is it that you would recommend this system to other professionals in your field? |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 3.0 T Neonatal MRI 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 scan procedure | 52 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Phase 1: Initial Feasibility Assessment | Breakdown of investigational device | 1 |
| Phase 1: Initial Feasibility Assessment | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | 3.0 T Neonatal MRI Scanner | — |
|---|---|---|
| Age, Categorical <=18 years | 52 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 Kingdom | 52 participants | — |
| Sex: Female, Male Female | 29 Participants | — |
| Sex: Female, Male Male | 23 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 54 |
| other Total, other adverse events | 1 / 54 |
| serious Total, serious adverse events | 0 / 54 |
Outcome results
Primary
Image Diagnostic Quality for Phase 1
Number of subject whose images were rated as Evaluable.
Time frame: 1 Day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3.0 T Neonatal MRI Scanner | Image Diagnostic Quality for Phase 1 | 24 Participants |
Primary
Image Diagnostic Quality for Phase 2
Number of subject whose images were rated as Evaluable.
Time frame: 1 Day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3.0 T Neonatal MRI Scanner | Image Diagnostic Quality for Phase 2 | 5 Participants |
Primary
Number of Participants Who Experienced an Adverse Event in Phase 1
Safety will be assessed based on the number of Adverse Events in Phase 1.
Time frame: 1 Day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3.0 T Neonatal MRI Scanner | Number of Participants Who Experienced an Adverse Event in Phase 1 | 1 Participants |
Primary
Number of Participants Who Experienced an Adverse Event in Phase 2
Safety will be assessed based on the number of Adverse Events in Phase 2.
Time frame: 1 Day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3.0 T Neonatal MRI Scanner | Number of Participants Who Experienced an Adverse Event in Phase 2 | 0 Participants |
Secondary
Bi-polar Product Description Scale
A measure of bi-polar items (opposite items), rated on a scale from 1 to 7. Closer to 1 indicates a measure closer to the first item and closer to 7 indicates a measure closer to the second item.
Time frame: 1 Day
Population: There were 54 enrolled subjects, with 2 withdrawn, resulting in 52 completed subjects for Phases 1 and 2 together. Additionally, the data from these 2 withdrawn subjects were not included in any statistical analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3.0 T Neonatal MRI Scanner | Bi-polar Product Description Scale | Learnable-Not Learnable | 1.25 score on a scale | Standard Deviation 0.44 |
| 3.0 T Neonatal MRI Scanner | Bi-polar Product Description Scale | Inefficient-Efficient | 6.47 score on a scale | Standard Deviation 0.5 |
| 3.0 T Neonatal MRI Scanner | Bi-polar Product Description Scale | Resistant-Responsive | 6.51 score on a scale | Standard Deviation 0.61 |
| 3.0 T Neonatal MRI Scanner | Bi-polar Product Description Scale | Annoying-Pleasing | 6.22 score on a scale | Standard Deviation 0.92 |
| 3.0 T Neonatal MRI Scanner | Bi-polar Product Description Scale | Satisfying-Dissatisfying | 1.92 score on a scale | Standard Deviation 1.06 |
| 3.0 T Neonatal MRI Scanner | Bi-polar Product Description Scale | Ineffective-Effective | 6.25 score on a scale | Standard Deviation 0.8 |
| 3.0 T Neonatal MRI Scanner | Bi-polar Product Description Scale | Fast-Slow | 1.57 score on a scale | Standard Deviation 1.2 |
| 3.0 T Neonatal MRI Scanner | Bi-polar Product Description Scale | Unfamiliar-Familiar | 6.37 score on a scale | Standard Deviation 0.63 |
| 3.0 T Neonatal MRI Scanner | Bi-polar Product Description Scale | Routine-Unusual | 1.65 score on a scale | Standard Deviation 0.96 |
| 3.0 T Neonatal MRI Scanner | Bi-polar Product Description Scale | Easy-Difficult | 1.53 score on a scale | Standard Deviation 0.7 |
| 3.0 T Neonatal MRI Scanner | Bi-polar Product Description Scale | Useful-Useless | 1.61 score on a scale | Standard Deviation 0.78 |
| 3.0 T Neonatal MRI Scanner | Bi-polar Product Description Scale | Bad-Good | 6.51 score on a scale | Standard Deviation 0.7 |
Secondary
Overall Experience With the Neonatal MR Scanner Device Summary
User survey results on a scale from 1 to 5, where 1 = strongly disagree and 5 = strongly agree. Question 1. I think that I would like to use this system frequently Question 2. I found the system unnecessarily complex Question 3. I thought the system was easy to use Question 4. I think that I would need support from a technician to be able to use this system Question 5. I found the various functions in this system were well integrated Question 6. I thought there was too much inconsistency in this system Question 7. I think that most people would learn to use this system very quickly Question 8. I found the system very cumbersome to use Question 9. I felt very confident using the system Question 10. I needed to learn a lot of things before I could get going with this system Question 11. I feel confident this system will meet my patient's needs Question 12. How likely is it that you would recommend this system to other professionals in your field?
Time frame: 1 Day
Population: There were 54 enrolled subjects, with 2 withdrawn, resulting in 52 completed subjects for Phases 1 and 2 together. Additionally, the data from these 2 withdrawn subjects were not included in any statistical analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3.0 T Neonatal MRI Scanner | Overall Experience With the Neonatal MR Scanner Device Summary | Question 1 | 4.13 score on a scale | Standard Deviation 0.4 |
| 3.0 T Neonatal MRI Scanner | Overall Experience With the Neonatal MR Scanner Device Summary | Question 2 | 1.77 score on a scale | Standard Deviation 0.47 |
| 3.0 T Neonatal MRI Scanner | Overall Experience With the Neonatal MR Scanner Device Summary | Question 3 | 4.25 score on a scale | Standard Deviation 0.44 |
| 3.0 T Neonatal MRI Scanner | Overall Experience With the Neonatal MR Scanner Device Summary | Question 4 | 1.90 score on a scale | Standard Deviation 0.45 |
| 3.0 T Neonatal MRI Scanner | Overall Experience With the Neonatal MR Scanner Device Summary | Question 5 | 4.02 score on a scale | Standard Deviation 0.24 |
| 3.0 T Neonatal MRI Scanner | Overall Experience With the Neonatal MR Scanner Device Summary | Question 6 | 2.17 score on a scale | Standard Deviation 0.68 |
| 3.0 T Neonatal MRI Scanner | Overall Experience With the Neonatal MR Scanner Device Summary | Question 7 | 4.20 score on a scale | Standard Deviation 0.43 |
| 3.0 T Neonatal MRI Scanner | Overall Experience With the Neonatal MR Scanner Device Summary | Question 8 | 1.73 score on a scale | Standard Deviation 0.45 |
| 3.0 T Neonatal MRI Scanner | Overall Experience With the Neonatal MR Scanner Device Summary | Question 9 | 4.12 score on a scale | Standard Deviation 0.38 |
| 3.0 T Neonatal MRI Scanner | Overall Experience With the Neonatal MR Scanner Device Summary | Question 10 | 1.88 score on a scale | Standard Deviation 0.38 |
| 3.0 T Neonatal MRI Scanner | Overall Experience With the Neonatal MR Scanner Device Summary | Question 11 | 4.06 score on a scale | Standard Deviation 0.42 |
| 3.0 T Neonatal MRI Scanner | Overall Experience With the Neonatal MR Scanner Device Summary | Question 12 | 4.15 score on a scale | Standard Deviation 0.5 |
Secondary
Per Subject Workflow and Transport Information
Summary of means and standard deviations.
Time frame: 1 Day
Population: There were 54 enrolled subjects, with 2 withdrawn, resulting in 52 completed subjects for Phases 1 and 2 together. Additionally, the data from these 2 withdrawn subjects were not included in any statistical analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3.0 T Neonatal MRI Scanner | Per Subject Workflow and Transport Information | MRI Scan time | 35.15 minutes | Standard Deviation 8.02 |
| 3.0 T Neonatal MRI Scanner | Per Subject Workflow and Transport Information | Time in sponsor swaddle | 66 minutes | Standard Deviation 13.73 |
| 3.0 T Neonatal MRI Scanner | Per Subject Workflow and Transport Information | Entire procedure time | 66.33 minutes | Standard Deviation 9.7 |
Secondary
Subject Change in Temperature
Time frame: 1 Day
Population: There were 54 enrolled subjects, with 2 withdrawn, resulting in 52 completed subjects for Phases 1 and 2 together. Additionally, the data from these 2 withdrawn subjects were not included in any statistical analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3.0 T Neonatal MRI Scanner | Subject Change in Temperature | 0.17 Degrees Celsius | Standard Deviation 0.23 |
Secondary
Summary of Image Quality and Assessment for Phase 1
Scores range from 1-Very Poor image quality to 5-Excellent image quality.
Time frame: 1 Day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3.0 T Neonatal MRI Scanner | Summary of Image Quality and Assessment for Phase 1 | Overall Quality | 3.57 score on a scale | Standard Deviation 0.773 |
| 3.0 T Neonatal MRI Scanner | Summary of Image Quality and Assessment for Phase 1 | Image Contrast | 3.85 score on a scale | Standard Deviation 0.834 |
| 3.0 T Neonatal MRI Scanner | Summary of Image Quality and Assessment for Phase 1 | Presence Artifact | 3.02 score on a scale | Standard Deviation 0.821 |
| 3.0 T Neonatal MRI Scanner | Summary of Image Quality and Assessment for Phase 1 | Signal to noise ratio | 3.72 score on a scale | Standard Deviation 0.926 |
| 3.0 T Neonatal MRI Scanner | Summary of Image Quality and Assessment for Phase 1 | Tissue Contrast | 3.98 score on a scale | Standard Deviation 0.766 |
| 3.0 T Neonatal MRI Scanner | Summary of Image Quality and Assessment for Phase 1 | Fat/Water Homogeneity | 3.64 score on a scale | Standard Deviation 0.673 |
Secondary
Summary of Image Quality and Assessments for Phase 2
Scores range from 1-Very Poor image quality to 5-Excellent image quality.
Time frame: 1 Day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3.0 T Neonatal MRI Scanner | Summary of Image Quality and Assessments for Phase 2 | Overall Quality | 4.2 score on a scale | Standard Deviation 0.447 |
| 3.0 T Neonatal MRI Scanner | Summary of Image Quality and Assessments for Phase 2 | Image Contrast | 4.4 score on a scale | Standard Deviation 0.548 |
| 3.0 T Neonatal MRI Scanner | Summary of Image Quality and Assessments for Phase 2 | Presence Artifact | 3.8 score on a scale | Standard Deviation 0.447 |
| 3.0 T Neonatal MRI Scanner | Summary of Image Quality and Assessments for Phase 2 | Signal to noise ratio | 4 score on a scale | Standard Deviation 0 |
| 3.0 T Neonatal MRI Scanner | Summary of Image Quality and Assessments for Phase 2 | Tissue Contrast | 4.2 score on a scale | Standard Deviation 0.837 |
| 3.0 T Neonatal MRI Scanner | Summary of Image Quality and Assessments for Phase 2 | Fat/Water Homogeneity | 4 score on a scale | Standard Deviation 0 |
Secondary
Technical Issues and Malfunctions
Number and type of technical issues and device malfunctions
Time frame: 1 Day
Population: There were 54 enrolled subjects, with 2 withdrawn, resulting in 52 completed subjects for Phases 1 and 2 together. Additionally, the data from these 2 withdrawn subjects were not included in any statistical analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3.0 T Neonatal MRI Scanner | Technical Issues and Malfunctions | Technical Issues | 0 number of occurrences |
| 3.0 T Neonatal MRI Scanner | Technical Issues and Malfunctions | Device Malfunction | 5 number of occurrences |