N/A
N=49
Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit (Firefly Sheffield)
Neonatal Neuroimaging
Bottom Line
View on ClinicalTrials.gov: NCT02785588 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Image Diagnostic Quality for Phase 1 — 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 3.0 T Neonatal MRI scanner (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GE Healthcare
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Image Diagnostic Quality for Phase 1 |
24 | — |
| PRIMARY Number of Participants Who Experienced an Adverse Event in Phase 1 |
1 | — |
| PRIMARY Image Diagnostic Quality for Phase 2 |
5 | — |
| PRIMARY Number of Participants Who Experienced an Adverse Event in Phase 2 |
— | — |
| SECONDARY Summary of Image Quality and Assessment for Phase 1 |
3.57; 3.85; 3.02; 3.72; 3.98; 3.64 | — |
| SECONDARY Summary of Image Quality and Assessments for Phase 2 |
4.2; 4.4; 3.8; 4; 4.2; 4 | — |
| SECONDARY Per Subject Workflow and Transport Information |
66; 66.33; 35.15 | — |
| SECONDARY Overall Experience With the Neonatal MR Scanner Device Summary |
4.13; 1.77; 4.25; 1.90; 4.02; 2.17 | — |
| SECONDARY Bi-polar Product Description Scale |
1.25; 6.47; 6.51; 6.22; 1.92; 6.25 | — |
| SECONDARY Technical Issues and Malfunctions |
0; 5 | — |
| SECONDARY Subject Change in Temperature |
0.17 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Currently admitted for treatment or observation at the investigational site at the time of enrolment;
- weight range less than 5.0 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 :
- Maximum width (shoulder-to-shoulder measurement) less than eighteen (18 cm).
- 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).
Data sourced from ClinicalTrials.gov (NCT02785588). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.