NCT04659486Unknown不适用
Prospective Studies in School-aged Children and Adolescents With COVID-19 Treated at HCFMUSP
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Quality of Life assessed by the Pediatric Quality of Life Inventory (Peds-QoL)
研究概览
简要总结
This is a protocol aimed at children and adolescents contaminated with COVID, treated at the Hospital das Clínicas, University of Sao Paulo, Brazil (HCFMUSP), in the recovery phase. The study aims to evaluate the spectrum of pathogenic lesions of the virus not only in the respiratory system, but digestive, immunological, neurological and others. Clinical, evolutionary, laboratory and functional parameters will be used.
详细描述
School-age children and adolescents COVID-19 survivors may have persistent inflammation, a chronic course of COVID-19, with isolated or concomitant aggressions of various organs and systems, making this disease a potential chronic condition, impacting aspects of quality of life related to health (HRQoL), physical and mental health. In addition, pediatric COVID-19 can induce autoimmunity (with the possibility of primary hypothyroidism and type I diabetes mellitus), delayed linear growth and delayed pubertal development, secondary immunodeficiency and present genetic polymorphisms in brain plasticity impacting rehabilitation. School-aged children and adolescents with COVID-19 could present muscle weakness, dysautonomy, asthenia and physical inactivity, so it is essential that safe and effective interventions are developed to maintain adequate levels of physical activity and that they can be implemented on a large scale. However, to date, there are no systematic longitudinal studies that have evaluated all these aspects in a pediatric population that survived COVID-19, particularly with chronic conditions and who were hospitalized in a tertiary service.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •school-age children and adolescents diagnosed with COVID-19
排除标准
- •school-age children and adolescents with MIS-C, who present: myocardial dysfunction, refractory cardiac arrhythmias, coronary artery aneurysms with or without thrombi, electrocardiographic alterations suggestive of myocardial infarction or ischemia and clinical signs of heart failure;
- •presence of any limitation or physical disability that prevents the practice of exercise;
- •pregnancy.
结局指标
主要结局
Quality of Life assessed by the Pediatric Quality of Life Inventory (Peds-QoL)
时间窗: Change from Baseline at 6 months
The instrument was translated and validated for the Brazilian population
次要结局
- Lactate dehydrogenase(Baseline, 3 months, 6 months, 12 months)
- Health-related quality of life assessed by the Pediatric Outcomes Data Collection Instrument(Baseline, 3 months, 6 months, 12 months)
- Inflammatory markers (C-reactive protein, fibrinogen, D-dimer and ferritin);(Baseline, 3 months, 6 months,12 months)
- Flow-volume loop assessed by spirometry(Baseline, 3 months, 6 months)
- Serum urea and creatinine(Baseline, 3 months, 6 months, 12 months)
- Pro-BNP(Baseline, 3 months, 6 months, 12 months)
- Lung abnormalities will be assessed by pulmonary computed tomography(Baseline, 3 months, 6 months, 12 months)
- Aspartate and alanine aminotransferase(Baseline, 3 months, 6 months, 12 months)
- Complete blood count (hemoglobin, leukocyte, lymphocyte and platelet count)(Baseline, 3 months, 6 months, 12 months)
- Triglycerides(Baseline, 3 months, 6 months, 12 months)
- Creatinine phosphokinase (CK)(Baseline, 3 months, 6 months, 12 months)
- Immunophenotyping of lymphocytes T cell lineages will be evaluated by flow cytometry(Baseline, 3 months, 6 months, 12 months)
- Serum levels of anti-Streptococcus pneumoniae IgG antibodies(Baseline, 3 months, 6 months, 12 months)
- Bone age will be assessed using non-dominant hand and wrist radiography(Baseline, 12 months)
- Bone mineral content will be assessed by Bone densitometry (DXA) in the region of the lumbar spine(Baseline, 3 months, 6 months, 12 months)
- Bone mineral density will be assessed by Bone densitometry (DXA) in the proximal femur(Baseline, 3 months, 6 months, 12 months)
- Amilase(Baseline, 3 months, 6 months, 12 months)
- Troponin T(Baseline, 3 months, 6 months, 12 months)
- Systolic and diastolic function will be assessed by echocardiogram(Baseline, 3 months, 6 months, 12 months)
- Pericardial effusion will be assessed by echocardiogram(Baseline, 3 months, 6 months, 12 months)
- Coronary arteries will be assessed by echocardiogram(Baseline, 3 months, 6 months, 12 months)
- Immunocompetence, including thymic function(Baseline, 3 months, 6 months, 12 months)
- Lipase(Baseline, 3 months, 6 months, 12 months)
- Evaluation of the thymus by the determination of TRECs (Thymic recent emigrant cells or T-cell receptor excision circles)(Baseline, 3 months, 6 months, 12 months)
- Changes in frequency of the autoantibodies of the thyroid gland(Baseline, 3 months, 6 months, 12 months)
- Changes in frequency of the anti-islet antibody of Langerhans will be assessed using indirect fluorescence(Baseline, 3 months, 6 months, 12 months)
- Changes in frequency of the anti-insulin antibody will be assessed by radioimmunoassay(Baseline, 3 months, 6 months, 12 months)
- Valve dysfunction will be assessed by echocardiogram(Baseline, 3 months, 6 months, 12 months)
- Ischemia will be assessed by echocardiogram(Baseline, 3 months, 6 months, 12 months)
- Leukogram will be assessed by leukocyte and lymphocyte counts(Baseline, 3 months, 6 months,, 12 months)
- Immunophenotyping of lymphocytes B cell lineages will be evaluated by flow cytometry(Baseline, 3 months, 6 months, 12 months)
- Immunophenotyping of lymphocytes NK cells will be evaluated by flow cytometry(Baseline, 3 months, 6 months, 12 months)
- Changes in frequency of the anti-GAD antibody will be assessed using immunoprecipitation(Baseline, 3 months, 6 months, 12 months)
- Linear growth will be assessed by using a standardized stadiometer, calculating standard deviation, growth curves, and growth speed(Baseline, 3 months, 6 months, 12 months)
- Bone mineral content will be assessed by Bone densitometry (DXA) in the whole body(Baseline, 3 months, 6 months, 12 months)
- Body composition (lean mass) will be assessed by Bone densitometry(Baseline, 3 months, 6 months, 12 months)
- Anti-pneumococcal vaccine response will be assessed by ELISA(Baseline, 3 months, 6 months, 12 months)
- Diagnosis of thyroid dysfunction will be assessed by thyroid profile (TSH, free T4 and T3)(Baseline, 3 months, 6 months, 12 months)
- Diagnosis of type 1 diabetes mellitus will be assessed by the metabolic profile (fasting glucose, glycated hemoglobin and C peptide)(Baseline, 3 months, 6 months,, 12 months)
- Development of puberty will be assessed according to the criteria of Tanner and Marshall in adolescents in the prepubertal age group(Baseline, 3 months, 6 months, 12 months)
- Bone mineral content will be assessed by Bone densitometry (DXA) in the proximal femur(Baseline, 3 months, 6 months, 12 months)
- Bone mineral density will be assessed by Bone densitometry (DXA) in the whole body(Baseline, 3 months, 6 months, 12 months)
- Mental health will be assessed by the "Depression, Anxiety and Stress Scale"(Baseline, 3 months, 6 months, 12 months)
- Blood flow will be assessed using a Doppler Ultrasound(Baseline, 3 months, 6 months, 12 months)
- Bone mineral density will be assessed by Bone densitometry (DXA) in the region of the lumbar spine(Baseline, 3 months, 6 months, 12 months)
- Body composition (visceral adipose tissue) will be assessed by Bone densitometry(Baseline, 3 months, 6 months, 12 months)
- Pediatric gait assessment will be assessed by an Actigraph (3D accelerometer) model G-Walk during the 6-minute walk test(Baseline, 3 months, 6 months, 12 months)
- Pediatric gait assessment will be assessed by an Actigraph (3D accelerometer) model G-Walk during the 10 meter gait test(Baseline, 3 months, 6 months, 12 months)
- Pediatric gait assessment will be assessed by musculoskeletal ultrasound(Baseline, 3 months, 6 months, 12 months)
- Physical activity levels assessed by ActivPAL(Baseline, 3 months, 6 months, 12 months)
- Bone biochemical and bone remodeling markers (calcium, phosphorus, 25OH alkaline phosphatase vitamin D, PTH, CTX, P1NP)(Baseline, 3 months, 6 months, 12 months)
- Genetic Polymorphism Analysis will be assessed by salting out methodology followed by q-PCR (Real-time PCR) using the TaqMan assay using Step One Plus equipment(Baseline, 3 months, 6 months, 12 months)
- Mental health will be assessed by the "Strengths and Weaknesses of Attention-deficit/hyperactivity disorder (ADHD) symptoms and Normal behaviors"(Baseline, 3 months, 6 months, 12 months)
- Mental health will be assessed by the "Strengths and Difficulties Questionnaire"(Baseline, 3 months, 6 months, 12 months)
- Body composition (fat mass) will be assessed by Bone densitometry(Baseline, 3 months, 6 months, 12 months)
- Pediatric gait assessment will be assessed by an Actigraph (3D accelerometer) model G-Walk used during the "timed up and go" test(Baseline, 3 months, 6 months, 12 months)
- Food consumption levels assessed by food records(Baseline, 3 months, 6 months, 12 months)
- Endothelial function will be assessed using a Doppler Ultrasound(Baseline, 3 months, 6 months, 12 months)
研究者
Bruno Gualano
Professor
University of Sao Paulo
研究点 (2)
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