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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI for Neonates | Experimental | All participants will receive an MRI in the NICU scanner in the GE OPTIMA 1.5T MRI at CCHMC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GE OPTIMA MR430s with HDX/GE Electronics | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beth M Kline-Fath, MD | 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 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | MRI for Neonates | MRI GE OPTIMA MR430s with HDX/GE Electronics: MRI scan |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | MRI for Neonates | MRI GE OPTIMA MR430s with HDX/GE Electronics: MRI scan |
| 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 Observed During and After Scanning. | Any observed physical changes either related or not related to the MRI was recorded during and after scanning. | All patients have undergone clinically indicated and ordered MRI's. | Posted | Count of Participants | Participants | Day 1 |
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1 day
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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 | MRI for Neonates | MRI GE OPTIMA MR430s with HDX/GE Electronics: MRI scan | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiration abnormal | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Beth Kline-Fath | Cincinnati Children's Hospital Medical Center | (513) 636-1856 | beth.kline-fath@cchmc.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 6, 2017 | Oct 1, 2020 | Prot_000.pdf |
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| Participants |
|
| Age, Continuous | Median | Full Range | days |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Anatomy scanned | Count of Participants | Participants |
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| 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. | All patients have undergone clinically indicated and ordered MRI's. | Posted | Count of Participants | Participants | Day 1 |
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| 615 |
| 0 |
| 615 |
| 4 |
| 615 |
| Apneic attack | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Sedative therapy | Surgical and medical procedures | MedDRA 10.0 | Non-systematic Assessment | The patient received 2 doses of PO versed. The patient recovered, no sequelae. The event was related to clinically indicated sedation given to the subject for a clinically indicated scan. |
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