Pilot Study: Safety of a Customized MRI System for Neonatal Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of Participants With Adverse Events as Measured by Vital Signs, Change in Temperature, and Physical Exam
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any infant admitted to the NICU at CCHMC
- •Medically stable as per the opinion of the attending neonatologist currently on service
- •Parental consent obtained
排除标准
- •Infants too large to fit in the customized NICU MRI system comfortably (expected to be infants >4.5 kg)
- •Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology
结局指标
主要结局
Number of Participants With Adverse Events as Measured by Vital Signs, Change in Temperature, and Physical Exam
时间窗: 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.
次要结局
- MRI Image Quality(Post MRI Scan for Each Infant)