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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety of a Customized NICU MRI System | Experimental | Device: GE OPTIMA MR430s with HDX/GE Electronics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GE OPTIMA MR430s with HDX/GE Electronics | Device | MRI scan(s) for no longer than 60 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post MRI Scan for Each Infant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles L Dumoulin, Ph.D. | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NICU, Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
All participants enrolled in the study, completed the study.
Patients, eligible to participate, were recruited from within the NICU beginning in February 2012 ending in April 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pilot Group | Patients who received an MRI. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pilot Group | Patients who had an MRI in the NICU scanner. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Number | Adverse Events | Day 1 |
|
|
Patients were monitored for approximately 2 hours after the MRI for Adverse Events for skin changes due to the monitor leads.
Patients' vital signs (heart rate and oxygen saturation) were measured and recorded during the MRI. The physician present performed a physical exam immediately after the MRI to assess for any skin changes due to the MRI scan process.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pilot Group | Patients who had an MRI in the NICU scanner. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Desaturation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Baby had a mild desaturation for about 5 seconds. It was unrelated to the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean Tkach | Cincinnati Children's Hospital Medical Center | 513-636-7166 | jean.tkach@cchmc.org |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| 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. | Number of NICU MRI Images with Equal or Better Quality than Adult Scanner Images | Number | Images | Post MRI Scan for Each Infant |
|
|
|
| 0 |
| 15 |
| 3 |
| 15 |
|
| Drop in Heart Rate | Cardiac disorders | Non-systematic Assessment | One baby had a drop in heart rate for about 5 seconds. |
|
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