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临床试验/NCT01801865
NCT01801865已完成不适用

Clinical Use of a New Neonatal MRI System

Children's Hospital Medical Center, Cincinnati2 个研究点 分布在 1 个国家目标入组 657 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
657
试验地点
2
主要终点
Number of Participants With Adverse Events as Observed During and After Scanning.

研究概览

简要总结

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).

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 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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Infants too large to fit in the customized NICU MRI system comfortably (expected to be infants heavier than 6 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 Observed During and After Scanning.

时间窗: Day 1

Any observed physical changes either related or not related to the MRI was recorded during and after scanning.

次要结局

  • Each Infant's Baseline Measurement for Weight Will be Recorded to Ensure the Infant is Less Than 6 kg.(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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