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| Name | Class |
|---|---|
| Capital Institute of Pediatrics, China | OTHER |
| The First Affiliated Hospital of Anhui Medical University | OTHER |
| China-Japan Friendship Hospital | OTHER |
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The study is designed to clarify the clinical characteristics, risk factors and long-term prognosis of children with 2019-nCoV infection in China.
As of February 10th, 2020, more than 40,000 human have been confirmed infected with a novel coronavirus (2019-nCoV) in China, with at least 800 reported deaths. Additional cases have been confirmed in multiple countries, and some are reported in children. Patients with confirmed 2019-nCoV infection have reported respiratory illness with fever, cough, et al. Some are asymptomatic carriers. However, there are relatively few diagnosed cases of children, and the long-term prognosis is unknown. Therefore, a multicenter observational study is needed to better understand the clinical characteristics of 2019-nCoV infection in children.
This observational study will last from February to December 2020. The patients enrolled were diagnosed with 2019-nCoV infection or 2019-nCoV pneumonia by Beijing Children's Hospital and other members of Chinese National Clinical Research Center for Respiratory Diseases in 2019-2020. At the same time, children hospitalized with pneumonia other than 2019-nCoV pneumonia during the same period are classified as the control group by 3~5:1 matching for age and sex to the 2019-nCoV group. After guardians signing the informed consent forms, all the participants' clinical data, laboratory examination results, image data and also the follow-up information after six months of their treatment will be collected.
The trial will be completed in 10 months, with subjects recruited from the hospitals that in partnership with clinical research collaboration of National Clinical Research Center for Respiratory Diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2019-nCoV infection group | Children hospitalized with direct laboratory confirmed of novel coronavirus with or without pneumonia are classified as the 2019-nCoV infection group. | ||
| Control group | Children hospitalized with pneumonia other than the novel coronavirus pneumonia during the same hospitalization period as 2019-nCoV infection group are classified as the control group. |
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| Measure | Description | Time Frame |
|---|---|---|
| The cure rate of 2019-nCoV. | Percentage | 6 months |
| The improvement rate of 2019-nCoV. | Percentage | 6 months |
| The incidence of long-term adverse outcomes. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of fever | Days | 2 weeks |
| Duration of respiratory symptoms | Days | 2 weeks |
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For the 2019-nCoV infection group
Inclusion Criteria:
Diagnosed with 2019-nCoV infection (with direct laboratory evidence).
Exclusion Criteria:
Subjects will be excluded if the children or their parents disagree to conduct this study.
For the control group
Inclusion Criteria:
Exclusion Criteria:
Subject will be excluded if she or he has one of the following:
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Patients who are aged 1day to 18 years, and diagnosed with 2019-nCoV infection/pneumonia or pneumonia other than novel coronavirus hospitalized in the same period in China.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Baoping Xu, MD,PhD | Contact | 861059616308 | xubaopingbch@163.com | |
| Kunling Shen, MD,PhD | Contact | kunlingshen1717@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Kunling Shen, MD,PhD | Beijing Children's Hospital of Capital Medical University, China | Principal Investigator |
| Tianyou Wang, MD,PhD | Beijing Children's Hospital of Capital Medical University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children's Hospital, | Beijing | China |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| The First Affiliated Hospital of Xiamen University |
| OTHER |
| Guangzhou Women and Children's Medical Center | OTHER |
| Shenzhen Children's Hospital | OTHER_GOV |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| The Affiliated Hospital Of Guizhou Medical University | OTHER |
| Hainan People's Hospital | OTHER |
| Children's Hospital of Hebei Province | OTHER |
| Wuhan Women and Children's Medical Center | OTHER |
| Changchun Children's Hospital | OTHER |
| Children's Hospital of Nanjing Medical University | OTHER |
| Jiangxi Province Children's Hospital | OTHER |
| Shengjing Hospital | OTHER |
| Shanxi Provincial Maternity and Children's Hospital | OTHER |
| Xian Children's Hospital | OTHER_GOV |
| Children's Hospital of Chongqing Medical University | OTHER |
| Tianjin Children's Hospital | OTHER |
| Tianjin Medical University Second Hospital | OTHER |
| Kunming Children's Hospital | OTHER |
| Second Affiliated Hospital of Wenzhou Medical University | OTHER |
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Serum
| Duration of hospitalization | Days | 2 weeks |
| Number of participant(s) need intensive care | 2 weeks |
| Number of participant(s) with acute respiratory distress syndrome | 2 weeks |
| Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al. | 2 weeks |
| Number of participant(s) who died during the trial | 10 months |
| Baoping Xu, MD,PhD | Beijing Children's Hospital of Capital Medical University, China | Principal Investigator |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |