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临床试验/NCT03560999
NCT03560999已完成不适用

Multi-Center: Non-Anesthetized Plexus Technique for Infant (BPBP) MRI Evaluation

Shriners Hospitals for Children6 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2017年3月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
6
主要终点
Whether Surgery Occurs

研究概览

简要总结

The investigators are studying the ability of a novel rapid magnetic resonance imaging (MRI) protocol to provide more accurate and earlier information about whether an infant with brachial plexus birth palsy will require nerve surgery.

详细描述

Brachial plexus birth palsy (BPBP) affects approximately 1 in 1,000 newborns, and though the majority of infants regain full function of the affected arm without nerve surgery, those with more severe nerve root injuries will require it. Currently, the best way to determine who will need surgery is to measure the trajectory of muscle recovery by serial clinical exams, but the optimal time for nerve surgery (before 3 months of age) is earlier than the time it usually takes to determine whether the infant needs surgery (up to 6 months.) A non-invasive diagnostic test that identifies the more severe injuries that require surgery earlier than serial exams would improve treatment timing, planning, and accuracy, and ultimately outcomes.

The investigators have developed a rapid MRI sequence with high spatial resolution and soft tissue contrast that does not require sedation or injection of a contrast agent, and that appeared to accurately assess the severity of nerve injury in infants with BPBP in a pilot study. This pilot study demonstrated that the protocol distinguishes infants who ultimately needed surgery from those who recovered spontaneously. The purpose of the current study is to enroll 100 infants at 3 centers (Shriners Hospital for Children Northern California, Boston Children's Hospital, and Gillette Children's Hospital) over a 5 year period to validate this imaging protocol as the new "gold standard" to determine whether infants with BPBP need surgery, so that individuals who need it could have surgery earlier when it is more effective, and the parents of the majority who will recover spontaneously could be spared months of worry.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Days 至 12 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of brachial plexus birth palsy.
  • Age at consent ≤4 months

排除标准

  • Bilateral brachial plexus birth palsy.
  • Age at MRI <28 days or >4 months old (patients can be enrolled prior to 28 days of age, but the imaging must occur in the 28 days to 4 months' time period). The lead PI will need to approve the enrollment of a subject who will have the MRI after 90 days of age.
  • Concomitant medical conditions that would preclude performance of or confound interpretation of MRI or any clinical assessment.

结局指标

主要结局

Whether Surgery Occurs

时间窗: by 6 months of age

The primary endpoint is the surgeon's decision for or against surgery, typically made by 6 months of age. Surgeons will make their decision based on all available clinical data, including the MRI, but will be blinded to the neuroradiologist's scoring of the SRS and its components.

次要结局

  • Intraoperative Findings(At time of surgery. Surgery occurs solely due to clinical reasons, so surgery timing (if it occurs at all) varies based on the clinical needs of the patient.)
  • AMS Scores (Hospital for Sick Children Active Movement Scale)(At follow up visits up to 30 months of age)
  • Toronto Scores(At follow up visits up to 30 months of age)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michelle James

Chief of Orthopaedic Surgery

Shriners Hospitals for Children

研究点 (6)

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