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临床试验/NCT05445531
NCT05445531Unknown不适用

Low-field Magnetic Resonance Imaging to Assess Changes in Pulmonary Function Parameters in Confirmed Pediatric SARS-CoV-2 Infection

University of Erlangen-Nürnberg Medical School2 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2022年7月8日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
111
试验地点
2
主要终点
Functional lung assessment (LF-MRI)

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. These viruses predominantly cause mild colds, but can sometimes cause severe pneumonia and pulmonary skeletal changes. By low-field gastric magnetic resonance imaging (NF-MRI), only a small number of structural, scarring changes were seen in a preliminary study of pediatric and adolescent patients with past SARS-CoV-2 infection. In contrast, however, extensive changes in ventilation and blood flow function of the lungs were seen.

The long-term consequences and spontaneous progression of these changes on imaging are completely unclear. The aim of this study is to assess the course of these functional lung changes in pediatric and adolescent patients and to validate them with other standard clinical procedures.

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 and pulmonary skeletal disease. While the molecular basis for the changes in lung tissue or multi-organ involvement have been described, the age-specific long-term consequences, especially in children and adolescents, remain largely unexplained and misunderstood today.

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 as well as 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 aperture (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 broad pediatric population without the need for sedation.

To date, no structural changes were revealed by means of this MRI technique - however, large defects in the area of ventilation and blood flow function of the lung are apparent in specific functional sequences. The aim of this study is to assess the course of these functional lung changes in pediatric and adolescent patients and to validate them with other standard clinical procedures.

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 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Control arm:
  • Inclusion Criteria:
  • Proof of SARS-CoV-2 infection and at least 2/3 times complete vaccination before infection (at least 14 days) (complete vaccination status according to German recommendations)
  • Long Covid criteria not met according to AWMF S1 guideline

排除标准

  • Acute SARS-CoV-2 infection and need for isolation
  • Necessary quarantine
  • Pregnancy, lactation
  • Indication of acute infection
  • Known pleural or pericardial effusion
  • Critical condition (need for respiratory support, ventilation, oxygen administration, shock, symptomatic heart failure)
  • Marked thoracic deformities
  • Previous lung surgery
  • Injuries that do not allow for physical stress testing
  • Refusal of MRI imaging
  • General contraindications to MRI examinations (e.g., electrical implants such as pacemakers or perfusion pumps, etc.)
  • History, clinical, or other suspicion of pulmonary disease
  • Current respiratory infection/symptomatology
  • Pain leading to respiratory limitation
  • Inhaled therapy (e.g., steroids or beta-mimetics)
  • Immunosuppression
  • Any condition that may lead to respiratory limitation (e.g., pain disorder)
  • Obesity (>97% of age percentile)
  • Recovered arm:
  • Inclusion Criteria:
  • Positive SARS-CoV-2 infection confirmed by PCR
  • Long Covid criteria not met according to AWMF S1 guideline
  • Exclusion Criteria:
  • Acute SARS-CoV-2 infection and need for isolation
  • Necessary quarantine
  • Pregnancy, lactation
  • Indication of acute infection
  • Known pleural or pericardial effusion
  • Critical condition (need for respiratory support, ventilation, oxygen administration, shock, symptomatic heart failure)
  • Marked thoracic deformities
  • Previous lung surgery
  • Injuries that do not allow for physical stress testing
  • Refusal of MRI imaging
  • General contraindications to MRI examinations (e.g., electrical implants such as pacemakers or perfusion pumps, etc.)
  • Long Covid arm:
  • Inclusion Criteria:
  • Positive SARS-CoV-2 infection confirmed by PCR
  • Long Covid criteria according to AWMF S1 guideline fulfilled
  • Exclusion Criteria:
  • Acute SARS-CoV-2 infection and need for isolation
  • Necessary quarantine
  • Pregnancy, lactation
  • Indication of acute infection
  • Known pleural or pericardial effusion
  • Critical condition (need for respiratory support, ventilation, oxygen administration, shock, symptomatic heart failure)
  • Marked thoracic deformities
  • Previous lung surgery
  • Injuries that do not allow for physical stress testing
  • Refusal of MRI imaging
  • General contraindications to MRI examinations (e.g., electrical implants such as pacemakers or perfusion pumps, etc.)

结局指标

主要结局

Functional lung assessment (LF-MRI)

时间窗: Baseline compared to 6 months

Change in functional lung parameters

次要结局

  • Cardiological functional diagnostics (HR)(Baseline compared to 6 months)
  • Nailfold capillaroscopy (capillaries)(Baseline compared to 6 months)
  • Blood sample (auto antibodies)(Baseline compared to 6 months)
  • Blood sample (CrP)(Baseline compared to 6 months)
  • Cardiological functional diagnostics (VT2)(Baseline compared to 6 months)
  • Cardiological functional diagnostics (BRR)(Baseline compared to 6 months)
  • Cardiological functional diagnostics (O2Pulse)(Baseline compared to 6 months)
  • Nailfold capillaroscopy (first row)(Baseline compared to 6 months)
  • Blood sample (antibodies)(Baseline compared to 6 months)
  • Blood sample (IL-6)(Baseline compared to 6 months)
  • Blood sample (Calpro)(Baseline compared to 6 months)
  • Cardiological functional diagnostics (VO2)(Baseline compared to 6 months)
  • Cardiological functional diagnostics (VO2max)(Baseline compared to 6 months)
  • Cardiological functional diagnostics (HRR)(Baseline compared to 6 months)
  • Cardiological functional diagnostics (VE)(Baseline compared to 6 months)
  • Cardiological functional diagnostics (Borg Scale)(Baseline compared to 6 months)
  • Blood sample (RT-DC)(Baseline compared to 6 months)
  • Morphologic lung assessment (LF-MRI)(Baseline compared to 6 months)
  • Cardiological functional diagnostics (VCO2)(Baseline compared to 6 months)
  • Blood sample (Coagulation)(Baseline compared to 6 months)
  • Cardiological functional diagnostics (BGA)(Baseline compared to 6 months)
  • Nailfold capillaroscopy (morphology)(Baseline compared to 6 months)
  • Cardiological functional diagnostics (Breath rate at VAT)(Baseline compared to 6 months)
  • Cardiological functional diagnostics (HRV)(Baseline compared to 6 months)
  • Blood sample (Blood count)(Baseline compared to 6 months)

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Sponsor

研究点 (2)

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