Portable MRI for Pediatric Hypoxic Ischemic Brain Injury (pMRI for pHIBI)
2026年8月11日 更新者：Jessica S. Wallisch、Children's Mercy Hospital Kansas City
Ultralow-Field Portable MRI for Detection of Pediatric Hypoxic Ischemic Brain Injury
This study will evaluate the sensitivity and specificity of low field portable MRI (pMRI) for detection of hypoxic ischemic brain injuries in pediatric patients compared to clinically obtained neuroimaging to define pediatric diagnostic limitations and to determine the diagnostic capabilities of this neuroimaging modality following optimization of image acquisition.
The results of this study will help determine optimal clinical implementation opportunities in pediatric patients.
研究概览
详细说明
Standard brain magnetic resonance imaging (MRI) is the gold-standard to diagnose acute ischemic brain injuries; however, it is not always feasible to obtain this standard MRI due to risks and contraindications. Some of the most common risks can include transport to the radiology department, especially with critically ill patients on life-saving medical devices, exposure to ionizing radiation, and contraindications can include incompatible surgical hardware in patients' bodies, amongst others.
Our institution has an FDA-cleared portable MRI (pMRI) by Hyperfine Research, Inc. (HRI). This device addresses many of the conventional MRI challenges by:
- Operating at very low magnetic field strengths strength (less than 0.2 T or approximately 10 times less than the field strength of conventional devices) and eliminating the need for special rooms or shielding. Family members and staff can remain at the patient's bedside.
- Minimizing conditions such as claustrophobia and anxiety with an open concept, transparent "helmet" to rest the head in during the exam.
- Portable and can maneuver through hospital environments and wheeled directly to a patient's bedside.
- Noise levels are substantially lower than conventional MRI systems, so hearing protection is optional for the patient. The sounds are described as vibrations that produce rhythmic tones.
研究类型
介入性
注册 (估计的)
200
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jessica S Wallisch, MD
- 电话号码：(816) 234-3041
- 邮箱：jwallisch@cmh.edu
研究联系人备份
- 姓名：Allison Scott, RN, CCRC
- 电话号码：(913) 515-7535
- 邮箱：abscott@cmh.edu
学习地点
-
-
Missouri
-
Kansas City、Missouri、美国、64108
- 招聘中
- Children's Mercy Hospital and Clinics
-
接触：
- Maura Sien, RT(R), CCRC
- 邮箱：mesien@cmh.edu
-
接触：
- Jessica Wallisch, MD
- 邮箱：jwallisch@cmh.edu
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
不
描述
Inclusion Criteria
- Patients hospitalized in the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or the Neonatal Intensive Care Unit
- Ages 0-17 years at study enrollment
- Acute neurologic deficit suspected secondary to Hypoxic Ischemic Brain Injury (HIBI) or patients at high risk for HIBI
Exclusion Criteria o Pregnancy Any patient who has a contraindication to having an MRI
Patients with a passive or active implant will:
•First be reviewed on MRISafety.com to determine MR conditionality •If device is listed as Conditional or Unsafe for a 1.5T or a 3T, device will then be reviewed by MRI Safety Officer or MRI Physician Section chief to determine true conditionality for the portable MRI
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：便携式核磁共振臂
所有注册的受试者均分配至第 1 组
|
Enrolled subjects will undergo a portable, ultralow-field MRI (pMRI) at the bedside in the ICU location within +/- 24 hours of a clinically obtained, conventional MRI and/or head CT
Remaining blood or cerebrospinal fluid samples from clinical testing will be scavenged at timepoints correlating to the radiology imaging.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Determine the sensitivity and specificity of pMRI for detection of acute pediatric focal ischemic brain injuries.
大体时间：During intensive care admittance, an average of 1 month
|
Perform pMRI on pediatric ICU patients within +/- 24 hours of a clinically obtained, conventional MRI.
Compare detection rates and severity of ischemia and cerebral edema by pMRI vs conventional MRI to determine sensitivity and specificity.
|
During intensive care admittance, an average of 1 month
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Calculate the sensitivity and specificity of pMRI for detection of acute pediatric global hypoxic-ischemic brain injuries
大体时间：During intensive care admittance, an average of 1 month
|
Perform pMRI on pediatric ICU patients within +/- 24 hours of a clinically obtained, conventional MRI that demonstrates acute global hypoxic-ischemic brain injury as read by a clinical neuroradiologist.
Compare detection rates and severity of acute global hypoxic-ischemic brain injury by pMRI vs conventional MRI to calculate sensitivity and specificity.
|
During intensive care admittance, an average of 1 month
|
|
Establish the sensitivity and specificity of pMRI relative to head CT for detection of cerebral edema and ischemic brain injury in critically ill patients deemed unstable for standard MRI.
大体时间：During intensive care admittance, an average of 1 month
|
Perform pMRI on pediatric ICU patients within +/- 24 hours of a clinically obtained, conventional head CT obtained for acute neurologic changes.
Compare detection rates and severity of cerebral edema and ischemia by pMRI vs head CT to establish sensitivity and specificity.
|
During intensive care admittance, an average of 1 month
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jessica S Wallisch, MD、Children's Mercy Kansas City
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年7月6日
初级完成 (估计的)
2027年12月1日
研究完成 (估计的)
2027年12月1日
研究注册日期
首次提交
2026年5月3日
首先提交符合 QC 标准的
2026年5月3日
首次发布 (实际的)
2026年5月11日
研究记录更新
最后更新发布 (实际的)
2026年8月13日
上次提交的符合 QC 标准的更新
2026年8月11日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- STUDY00003934
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
De-identified IPD will be made available upon reasonable request.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
是的
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.