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Low-field Magnetic Resonance Imaging in Pediatric Post Covid-19

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05445531
Acronym
FASCINATE
Enrollment
111
Registered
2022-07-06
Start date
2022-07-08
Completion date
2023-03-31
Last updated
2022-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, COVID-19 Respiratory Infection, Long COVID

Keywords

COVID-19, Long COVID, post COVID

Brief summary

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.

Detailed description

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.

Interventions

Functional and morphologic imaging of the lungs

Imaging of nailfold microvasculature

DIAGNOSTIC_TESTSpiroergometry

Cardiopulmonary exercise testing

DIAGNOSTIC_TESTRealtime deformability cytometry

High-throughput measurement of cell deformability and physical properties

Sponsors

University of Erlangen-Nürnberg Medical School
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

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

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.) * 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

Design outcomes

Primary

MeasureTime frameDescription
Functional lung assessment (LF-MRI)Baseline compared to 6 monthsChange in functional lung parameters

Secondary

MeasureTime frameDescription
Cardiological functional diagnostics (VO2)Baseline compared to 6 monthsOxygen uptake (VO2)
Cardiological functional diagnostics (VO2max)Baseline compared to 6 monthsPeak oxygen uptake (VO2max)
Cardiological functional diagnostics (VT2)Baseline compared to 6 monthsVentilatory anaerobic threshold (VT2)
Cardiological functional diagnostics (VCO2)Baseline compared to 6 monthsCarbon dioxide output (VCO2)
Cardiological functional diagnostics (HR)Baseline compared to 6 monthsHeart rate (HR)
Cardiological functional diagnostics (HRR)Baseline compared to 6 monthsHeart Rate Reserve (HRR)
Cardiological functional diagnostics (Breath rate at VAT)Baseline compared to 6 monthsBreath rate at VAT
Cardiological functional diagnostics (BRR)Baseline compared to 6 monthsBreath rate reserve (BRR)
Cardiological functional diagnostics (VE)Baseline compared to 6 monthsMinute ventilation (VE)
Cardiological functional diagnostics (O2Pulse)Baseline compared to 6 monthsO2Pulse
Cardiological functional diagnostics (HRV)Baseline compared to 6 monthsHeart rate variability (HRV)
Cardiological functional diagnostics (Borg Scale)Baseline compared to 6 monthsExercise capacity nach Borg Scale
Morphologic lung assessment (LF-MRI)Baseline compared to 6 monthsMorphologic changes in lung parenchyma
Nailfold capillaroscopy (capillaries)Baseline compared to 6 monthsNumber of capillaries in first row
Nailfold capillaroscopy (first row)Baseline compared to 6 monthsNumber of capillaries in first row
Nailfold capillaroscopy (morphology)Baseline compared to 6 monthsMorphology of capillaries
Blood sample (antibodies)Baseline compared to 6 monthsSARS-CoV2-antibodies
Blood sample (auto antibodies)Baseline compared to 6 monthsAutoantibodies against G-protein receptors
Blood sample (RT-DC)Baseline compared to 6 monthsRealtime deformability cytometry
Blood sample (Blood count)Baseline compared to 6 monthsBlood count
Blood sample (IL-6)Baseline compared to 6 monthsInterleukin-6 (IL-6)
Blood sample (CrP)Baseline compared to 6 monthsC-reactive proteine (CrP)
Blood sample (Calpro)Baseline compared to 6 monthsCalprotectin (Calpro)
Blood sample (Coagulation)Baseline compared to 6 monthsCoagulation factors (Coagulation)
Cardiological functional diagnostics (BGA)Baseline compared to 6 monthsCapillary blood gas and lactate (BGA)

Countries

Germany

Contacts

Primary ContactFerdinand Knieling, MD
ferdinand.knieling@uk-erlangen.de+49913185

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026