NICU MRI
Conditions
Keywords
NICU, MRI, Neonatal, Cincinnati
Brief summary
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.
Detailed description
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.
Interventions
MRI scan
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Any infant admitted to CCHMC * Have a medical condition for which an MRI exam is indicated, as determined by the attending neonatologist
Exclusion criteria
* Infants too large to fit in the customized NICU MRI system comfortably (generally infants \> 6 kg) * Standard MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events as Observed During and After Scanning. | Day 1 | Any observed physical changes will be recorded during and after scanning |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Each Infant's Baseline Measurement for Weight Will be Recorded. | Day 1 | These measures will be used in order to facilitate future design of coils and transport tables for the customized MRI system. |
| Each Infant's Anatomy Scanned Will be Obtained. | Day 1 | The anatomy used will be used in order to facilitate understand the need for specific coils for the customized MRI system. |
| Baseline Measurement for Days Old Will be Recorded. | Day 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MRI for Neonates MRI
GE OPTIMA MR430s with HDx/GE Electronics: MRI scan | 386 |
| Total | 386 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Clinical exam moved to another scanner | 7 |
| Overall Study | Clinical order cancelled | 4 |
| Overall Study | Neonate did not settle down for the scan | 1 |
Baseline characteristics
| Characteristic | MRI for Neonates | — |
|---|---|---|
| Age, Categorical <=18 years | 386 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Age, Continuous | 20 days | — |
| Anatomy scanned Brain | 365 Participants | — |
| Anatomy scanned Brain and Neonate Spine | 2 Participants | — |
| Anatomy scanned Chest | 4 Participants | — |
| Anatomy scanned Spine | 14 Participants | — |
| Anatomy scanned Whole Body | 1 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 170 Participants | — |
| Sex: Female, Male Male | 216 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 374 |
| other Total, other adverse events | 0 / 374 |
| serious Total, serious adverse events | 0 / 374 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MRI for Neonates | Number of Participants With Adverse Events as Observed During and After Scanning. | 0 Participants |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MRI for Neonates | Baseline Measurement for Days Old Will be Recorded. | 20 days |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MRI for Neonates | Each Infant's Anatomy Scanned Will be Obtained. | Brain | 357 Participants |
| MRI for Neonates | Each Infant's Anatomy Scanned Will be Obtained. | Brain and Neonate Spine | 1 Participants |
| MRI for Neonates | Each Infant's Anatomy Scanned Will be Obtained. | Chest | 2 Participants |
| MRI for Neonates | Each Infant's Anatomy Scanned Will be Obtained. | Spine | 13 Participants |
| MRI for Neonates | Each Infant's Anatomy Scanned Will be Obtained. | Whole Body | 1 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MRI for Neonates | Each Infant's Baseline Measurement for Weight Will be Recorded. | 2.92 kg |