Magnetic Resonance Imaging
Conditions
Keywords
NICU, MRI, Neonatal
Brief summary
The purpose of the present study is to make medically indicated state of the art/high end magnetic resonance imaging (MRI) exams available to all infants in the Cincinnati Children's Hospital Medical Center (CCHMC) Neonatal Intensive Care Unit (NICU).
Detailed description
The current practice of transferring infants from the Neonatal Intensive Care Unit (NICU) to radiology departments and imaging in adult-sized magnetic resonance imaging (MRI) scanners is associated with significant safety and image quality issues. For these reasons, the smallest and/or sickest neonates are typically precluded from receiving an MRI exam. The overreaching 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. To expand the imaging capabilities of the NICU MRI system, the measurement control electronics and operating system software of the FDA cleared imaging 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). The present protocol builds and expands upon the previous to use the integrated NICU MRI system to perform MRI exams in the neonatal population.
Interventions
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 the NICU at CCHMC * Have a medical condition for which an MRI exam is indicated, as determined by the attending neonatologist * Able to maintain body temperature for at least 90 minutes without the aid of an incubator or radiant warmer int he opinion of the attending neonatologist * Parental/LAR permission obtained
Exclusion criteria
* Infants too large to fit in the customized NICU MRI system comfortably (expected to be infants heavier than 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 either related or not related to the MRI was recorded during and after scanning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Each Infant's Baseline Measurement for Weight Will be Recorded to Ensure the Infant is Less Than 6 kg. | Day 1 | These measures will be used in order to facilitate future design of coils and transport tables for the customized MRI system. |
Countries
United States
Participant flow
Pre-assignment details
The attending neonatologist determined whether the MRI scan was done with or without sedation. If possible, infants were scanned without sedation. Infants were prepared for the MRI exam by switching all monitoring devices over to MRI compatible monitors and provided with hearing protection.
Participants by arm
| Arm | Count |
|---|---|
| MRI for Neonates MRI
GE OPTIMA MR430s with HDX/GE Electronics: MRI scan | 615 |
| Total | 615 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Patients scanned on another MRI scanner | 35 |
| Overall Study | Physician Decision | 7 |
Baseline characteristics
| Characteristic | MRI for Neonates | — |
|---|---|---|
| Age, Categorical <=18 years | 615 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Age, Continuous | 18.25 days | — |
| Anatomy scanned Abdomen | 7 Participants | — |
| Anatomy scanned Brain | 517 Participants | — |
| Anatomy scanned Brain and Abdomen | 2 Participants | — |
| Anatomy scanned Brain and Chest | 7 Participants | — |
| Anatomy scanned Brain and Spine | 41 Participants | — |
| Anatomy scanned Chest | 5 Participants | — |
| Anatomy scanned Chest and Spine | 1 Participants | — |
| Anatomy scanned Orbit/Face/Neck | 7 Participants | — |
| Anatomy scanned Pelvis | 1 Participants | — |
| Anatomy scanned Pelvis and Extremity | 2 Participants | — |
| Anatomy scanned Spine | 23 Participants | — |
| Anatomy scanned Spine and Pelvis | 2 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 280 Participants | — |
| Sex: Female, Male Male | 335 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 615 |
| other Total, other adverse events | 4 / 615 |
| serious Total, serious adverse events | 0 / 615 |
Outcome results
Primary
Number of Participants With Adverse Events as Observed During and After Scanning.
Any observed physical changes either related or not related to the MRI was recorded during and after scanning.
Time frame: Day 1
Population: All patients have undergone clinically indicated and ordered MRI's.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MRI for Neonates | Number of Participants With Adverse Events as Observed During and After Scanning. | 4 Participants |
Secondary
Each Infant's Baseline Measurement for Weight Will be Recorded to Ensure the Infant is Less Than 6 kg.
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
Population: All patients have undergone clinically indicated and ordered MRI's.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MRI for Neonates | Each Infant's Baseline Measurement for Weight Will be Recorded to Ensure the Infant is Less Than 6 kg. | 615 Participants |