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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
111
Functional and morphologic imaging of the lungs
Imaging of nailfold microvasculature
Cardiopulmonary exercise testing
High-throughput measurement of cell deformability and physical properties
University Hospital Erlangen
Erlangen, Bavaria, Germany
RECRUITINGFunctional lung assessment (LF-MRI)
Change in functional lung parameters
Time frame: Baseline compared to 6 months
Morphologic lung assessment (LF-MRI)
Morphologic changes in lung parenchyma
Time frame: Baseline compared to 6 months
Cardiological functional diagnostics (VO2)
Oxygen uptake (VO2)
Time frame: Baseline compared to 6 months
Cardiological functional diagnostics (VO2max)
Peak oxygen uptake (VO2max)
Time frame: Baseline compared to 6 months
Cardiological functional diagnostics (VT2)
Ventilatory anaerobic threshold (VT2)
Time frame: Baseline compared to 6 months
Cardiological functional diagnostics (VCO2)
Carbon dioxide output (VCO2)
Time frame: Baseline compared to 6 months
Cardiological functional diagnostics (HR)
Heart rate (HR)
Time frame: Baseline compared to 6 months
Cardiological functional diagnostics (HRR)
Heart Rate Reserve (HRR)
Time frame: Baseline compared to 6 months
Cardiological functional diagnostics (Breath rate at VAT)
Breath rate at VAT
Time frame: Baseline compared to 6 months
Cardiological functional diagnostics (BRR)
Breath rate reserve (BRR)
Time frame: Baseline compared to 6 months
Cardiological functional diagnostics (VE)
Minute ventilation (VE)
Time frame: Baseline compared to 6 months
Cardiological functional diagnostics (O2Pulse)
O2Pulse
Time frame: Baseline compared to 6 months
Cardiological functional diagnostics (HRV)
Heart rate variability (HRV)
Time frame: Baseline compared to 6 months
Cardiological functional diagnostics (Borg Scale)
Exercise capacity nach Borg Scale
Time frame: Baseline compared to 6 months
Cardiological functional diagnostics (BGA)
Capillary blood gas and lactate (BGA)
Time frame: Baseline compared to 6 months
Nailfold capillaroscopy (capillaries)
Number of capillaries in first row
Time frame: Baseline compared to 6 months
Nailfold capillaroscopy (first row)
Number of capillaries in first row
Time frame: Baseline compared to 6 months
Nailfold capillaroscopy (morphology)
Morphology of capillaries
Time frame: Baseline compared to 6 months
Blood sample (antibodies)
SARS-CoV2-antibodies
Time frame: Baseline compared to 6 months
Blood sample (auto antibodies)
Autoantibodies against G-protein receptors
Time frame: Baseline compared to 6 months
Blood sample (RT-DC)
Realtime deformability cytometry
Time frame: Baseline compared to 6 months
Blood sample (Blood count)
Blood count
Time frame: Baseline compared to 6 months
Blood sample (IL-6)
Interleukin-6 (IL-6)
Time frame: Baseline compared to 6 months
Blood sample (CrP)
C-reactive proteine (CrP)
Time frame: Baseline compared to 6 months
Blood sample (Calpro)
Calprotectin (Calpro)
Time frame: Baseline compared to 6 months
Blood sample (Coagulation)
Coagulation factors (Coagulation)
Time frame: Baseline compared to 6 months
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