An interventional study of GE OPTIMA MR430s with HDx/GE Electronics in NICU MRI, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Diagnostic
The purpose of the present study is to continue clinical scanning on the NICU MRI with improved administrative processes and procedures, thereby making medically indicated, state of the art/high end MRI exams available to all infants treated at CCHMC.
There are significant safety and image quality issues associated with transferring neonates from the Neonatal Intensive Care Unit (NICU) to the main Radiology Department for imaging in an adult-sized magnetic resonance imaging (MRI) scanner. For these reasons, the smallest and/or sickest neonates are typically precluded from receiving an MRI exam. The goal of our research effort is to bring high-performance MRI into the NICU so that all neonates can benefit from the same quality of diagnostic imaging as adults. To accomplish this, we have converted a commercial small-bore 1.5 Tesla (T) MRI scanner designed for orthopedic use into a neonatal MRI system optimized for whole body imaging of neonates (NICU MRI). To expand the imaging capabilities of the NICU MRI system, the measurement control electronics and operating system software of the FDA cleared OPTIMA platform have been augmented with state of the art HDX electronics and software currently used on a conventional commercially available adult sized whole body MRI scanner. The clinical safety of the integrated HDX/OPTIMA NICU MRI system and its ability to produce diagnostic image quality has been shown in 15 pilot patients (CCHMC Protocol 2011-2045). Further we have scanned almost 600 patients under a prior protocol (CCHMC Protocol 2011-2850) without an adverse event.
The present protocol seeks to allow continued performance of clinical MRI exams on the NICU magnet with improved administrative processes and procedures. NICU patients for whom an MRI exam is medically indicated will be recruited for the present study. Images will be obtained using both the FDA cleared OPTIMA NICU MRI platform and the integrated HDX/OPTIMA NICU MRI platform with the additional HDX images augmenting the OPTIMA images and contributing to diagnosis and guidance of subsequent clinical management. The specific MR imaging methods/procedures utilized will be determined by the type of exam to be performed and the medical indication. All of the MR images obtained will be reviewed by a board certified pediatric radiologist as part of clinical care and a clinical report will be generated and included in the infant's medical record.
Exclusion Criteria:
MRI
Device: GE OPTIMA MR430s with HDx/GE Electronics
MRI scan
Number of Participants With Adverse Events as Observed During and After Scanning.
Any observed physical changes will be recorded during and after scanning
Time frame: Day 1
Each Infant's Baseline Measurement for Weight Will be Recorded.
These measures will be used in order to facilitate future design of coils and transport tables for the customized MRI system.
Time frame: Day 1
Each Infant's Anatomy Scanned Will be Obtained.
The anatomy used will be used in order to facilitate understand the need for specific coils for the customized MRI system.
Time frame: Day 1
Baseline Measurement for Days Old Will be Recorded.
These measures will be used in conjunction with the weight at the time of scan to facilitate future design of coils and transport tables for the customized MRI system.
Time frame: Day 1
| Milestone | MRI for Neonates |
|---|---|
| Started | 386 |
| Completed | 374 |
| Not completed | 12 |
| Withdrew: Clinical exam moved to another scanner | 7 |
| Withdrew: Clinical order cancelled | 4 |
| Withdrew: Neonate did not settle down for the scan | 1 |
Any observed physical changes will be recorded during and after scanning
| Participants | MRI for Neonates |
|---|---|
| Number of Participants With Adverse Events as Observed During and After Scanning. | 0 |
These measures will be used in order to facilitate future design of coils and transport tables for the customized MRI system.
| kg | MRI for Neonates |
|---|---|
| Each Infant's Baseline Measurement for Weight Will be Recorded. | 2.92 (0.54 to 4.89) |
The anatomy used will be used in order to facilitate understand the need for specific coils for the customized MRI system.
| Participants | MRI for Neonates |
|---|---|
| Brain | 357 |
| Brain and Neonate Spine | 1 |
| Chest | 2 |
| Spine | 13 |
| Whole Body | 1 |
These measures will be used in conjunction with the weight at the time of scan to facilitate future design of coils and transport tables for the customized MRI system.
| days | MRI for Neonates |
|---|---|
| Baseline Measurement for Days Old Will be Recorded. | 20 (1 to 155) |
Collected over Time that participant was in the NICU scanner for their clinically indicated scan (length of scan varies based on standard of care exam).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MRI for Neonates | 0/374 (0%) | 0/374 (0%) | 0/374 (0%) |
Neonates
| Age, Categorical(Participants) | MRI for Neonates |
|---|---|
| <=18 years | 386 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(days) | MRI for Neonates |
|---|---|
| Median | 20 (1 to 155) |
| Sex: Female, Male(Participants) | MRI for Neonates |
|---|---|
| Female | 170 |
| Male | 216 |
| Race and Ethnicity Not Collected(Participants) | MRI for Neonates |
|---|
| Anatomy scanned(Participants) | MRI for Neonates |
|---|---|
| Brain | 365 |
| Brain and Neonate Spine | 2 |
| Chest | 4 |
| Spine | 14 |
| Whole Body | 1 |
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Children's Hospital Medical Center, Cincinnati