A Clinical Observational Follow-up Study of European Pediatric Cases of Acute Flaccid Myelitis Associated With EV-D68 Infection.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Total Hammersmith Functional Motor scale- score at follow-up
研究概览
简要总结
The study is a follow-up study on children with acute flaccid paresis associated with enterovirus D68 infection. Only children living in Europe are eligible. The study aim is to clarify the outcome of the disease and investigate possible clinical correlation with outcome, including initial severity, demographic characteristics, treatment and MRI findings.
详细描述
Title: Clinical observational follow-up study of children with Acute Flaccid Myelitis associated with EV-D68 infection- a cross European collaboration.
Study objectives: To study the clinical outcome and function of patients with Acute Flaccid Myelitis associated with enterovirus (EV)-D68 infection after 1 to 3 years, in order to assist clinicians in providing prognoses for patients and to guide further investigation.
Primary objective will be:
• Functional assessment using the Hammersmith Functional Motor Scale (HFMS) -score at follow up; 1, 2 and three years depending on time of debut
Secondary objectives are to describe these secondary outcomes and their changes over time, from onset to 1, 2 and 3 years, depending on time of debut:
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
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute flaccid paresis (AFP) at onset, and
- •Enterovirus D-68 polymerase chain reaction (PCR) positive in any specimen in a timely sample (+/- 3 weeks from onset of paresis), and
- •Age <18 years at onset, and
- •Magnetic resonance imaging (MRI) of spine and brain at onset with signs of myelitis.
排除标准
- •Major trauma
- •central nervous system (CNS) malignancy
- •Bleeding or infarctions in CNS
- •Previous demyelinating disease
- •Other infections cause of myelitis is more likely
- •Patient and/or legal guardian is not able/willing to sign the consent form
结局指标
主要结局
Total Hammersmith Functional Motor scale- score at follow-up
时间窗: 1 year
O'Hagen, J. M., et al. (2007). "An expanded version of the Hammersmith Functional Motor Scale for SMA II and III patients." Neuromuscul Disord 17(9-10): 693-697.Neurol. 2003;7(4):155-9. The scale is a 33 items evaluation (0, 1 or 2 points in each item) and results in an overall functional score. Range: 0-66, with a higher score reflecting better performance. No sub-scores will be used.
次要结局
未报告次要终点
研究者
Helle Cecilie Viekilde Pfeiffer
Researcher, Pricipal investigator, PhD, Department of Child Neurology
Oslo University Hospital