Low-fielD magnEtiC Resonance Imaging of pulmonarY Parenchyma Changes Associated wiTh Confirmed SARS-CoV-2 Infection in Children and Adolescents
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Low-field magnetic resonance imaging
研究概览
简要总结
SARS-CoV-2 (Severe acute respiratory syndrome coronavirus type 2) is a new coronavirus and identified causative agent of COVID-19 disease. They predominantly cause mild colds but can sometimes cause severe pneumonia. The long-term consequences are still largely unexplained and misunderstood, especially in children and adolescents. The aim of this study is to assess the frequency of pulmonary skeletal changes in pediatric and adolescent patients using low-field magnetic resonance imaging (LF-MRI) in the setting of proven past SARS-CoV-2 infection.
详细描述
SARS-CoV-2 (Severe acute respiratory syndrome coronavirus type 2) is a new coronavirus and identified causative agent of COVID-19 disease. They predominantly cause mild colds, but can sometimes cause severe pneumonia. While the molecular basis for the changes in lung tissue or multi-organ involvement has been described, the age-specific long-term consequences, especially in children and adolescents, are still largely unexplained and not understood. Early publications from the primarily affected Chinese provinces described rather mild, partly asymptomatic courses in children. This is consistent with the observation that the risk of severe COVID-19 disease increases steeply from the age of 70 years, and is also determined by the severity of obesity and other risk factors. Developmental expression of tissue factors may be one reason for the relative protection of younger patients from severe courses of the disease.
However, it is now becoming increasingly clear that some individuals with milder initial symptoms of COVID-19 may suffer from variable and persistent symptoms for many months after initial infection - this includes children. A modern low-field MRI is located in Erlangen, Germany. This technique has already been used to demonstrate persistent damage to lung tissue in adult patients after COVID-19. The device with a field strength of 0.55 Tesla (T) currently has the world's largest bore (and is thus particularly suitable for patients with claustrophobia, among other things), a very quiet operating noise, and lower energy absorption in the tissue due to the weaker magnetic field than MRI scanners with 1.5T or 3T. This allows MRI imaging in a very wide pediatric population without the need for sedation.
The purpose of this study is to assess the frequency of lung parenchymal changes using low-field magnetic resonance imaging (LF-MRI) in pediatric and adolescent patients with past SARS-CoV-2 infection detected by PCR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Covid-19 group
- •Inclusion Criteria:
- •(Past) Positive SARS-CoV-2 Infection (PCR proven)
- •Age 5 to <18 years
排除标准
- •Acute SARS-CoV-2 Infection and Isolation
- •Quarantine
- •Pregnancy
- •Critical Illness
- •No consent to LF_MRI
- •General contraindications for LF-MRI, such as electrical implants, pace makers, perfusion pumps)
- •Healthy controls
- •Inclusion Criteria:
- •Age 5 to <18 years
- •Exclusion Criteria:
- •(Past) Positive SARS-CoV-2 Infection (PCR or antigen test proven)
- •Suspect for lung disease
- •Acute respiratory infection/symptomatic
- •Acute SARS-CoV-2 Infection and Isolation
- •Quarantine
- •Pregnancy
- •Critical Illness
- •No consent to LF_MRI
- •General contraindications for LF-MRI, such as electrical implants, pace makers, perfusion pumps)
结局指标
主要结局
Low-field magnetic resonance imaging
时间窗: Single time point (1 day)
Lung parenchymal changes (Ground-glass opacification/opacity (GGO))
次要结局
- Blood sample: D-dimers(Single time point (1 day))
- Blood sample: IL-6(Single time point (1 day))
- Blood sample: Monocytes(Single time point (1 day))
- Blood sample: C-reactive protein(Single time point (1 day))
- Low-field magnetic resonance imaging(Single time point (1 day))
- Blood sample: Serum(Single time point (1 day))
- Blood sample: Leucocytes(Single time point (1 day))
- Blood sample: Erythrocytes(Single time point (1 day))