Safety of a Customized NICU MRI System
Conditions
Keywords
NICU, MRI, Neonatal, Safety, Efficacy, Cincinnati
Brief summary
The purpose of this study is to determine the safety of a customized MRI scanner and gather preliminary data on image quality in a group of 10 medically stable infants admitted to the Neonatal Intensive Care Unit (NICU) at Cincinnati Children's Hospital Medical Center (CCHMC).
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 potential of MRI for diagnosing disease in neonates has yet to be fully realized. The overreaching goal of our research effort is to bring high-performance MRI into the NICU so that 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. The purpose of this initial study is to determine the safety of the customized scanner installed in the NICU at Cincinnati Children's Hospital Medical Center (CCHMC) and gather preliminary data on image quality in a group of 10 medically stable infants admitted to the CCHMC NICU.
Interventions
MRI scan(s) for no longer than 60 minutes
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Any infant admitted to the NICU at CCHMC * Medically stable as per the opinion of the attending neonatologist currently on service * Parental consent obtained
Exclusion criteria
* Infants too large to fit in the customized NICU MRI system comfortably (expected to be infants \>4.5 kg) * Standard MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events as Measured by Vital Signs, Change in Temperature, and Physical Exam | Day 1 | Heart rate and oxygen saturation will be measured every 15+/- 5 minutes. The infants' temperatures will be taken immediately before the MRI and again immediately after the MRI. A physical exam will be performed both immediately before and immediately after the MRI to assess for any physical changes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MRI Image Quality | Post MRI Scan for Each Infant | The following measures will be individually evaluated and compared to similar images previously acquired on an adult scanner: Overall Study Quality, Motion, Spatial Resolution, Signal to Noise, and Contrast. |
Countries
United States
Participant flow
Recruitment details
Patients, eligible to participate, were recruited from within the NICU beginning in February 2012 ending in April 2012.
Pre-assignment details
All participants enrolled in the study, completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Pilot Group Patients who had an MRI in the NICU scanner. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Pilot Group |
|---|---|
| Age, Categorical <=18 years | 15 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | .19 years STANDARD_DEVIATION 0.09 |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Number of Participants With Adverse Events as Measured by Vital Signs, Change in Temperature, and Physical Exam
Heart rate and oxygen saturation will be measured every 15+/- 5 minutes. The infants' temperatures will be taken immediately before the MRI and again immediately after the MRI. A physical exam will be performed both immediately before and immediately after the MRI to assess for any physical changes.
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pilot Group | Number of Participants With Adverse Events as Measured by Vital Signs, Change in Temperature, and Physical Exam | 0 Adverse Events |
Secondary
MRI Image Quality
The following measures will be individually evaluated and compared to similar images previously acquired on an adult scanner: Overall Study Quality, Motion, Spatial Resolution, Signal to Noise, and Contrast.
Time frame: Post MRI Scan for Each Infant
Population: Number of NICU MRI Images with Equal or Better Quality than Adult Scanner Images
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pilot Group | MRI Image Quality | 15 Images |