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The need for glucocorticoid therapy in children with severe community-acquired pneumonia in the acute phase of the disease remains unclear. The implementation of this study could provide strong evidence on the need for adjuvant glucose therapy in children with severe community-acquired pneumonia.
The use of glucocorticoid for severe community-acquired pneumonia in children is still controversial in clinic. There is still a lack of high quality clinical research results in this field. That's the purpose of this study. The study used oral glucocorticoids and placebos. It was a multicenter clinical study involving 160 people. The enrolled subjects were treated for 5 days after basic assessment, and the use of experimental drugs and changes in clinical manifestations and laboratory examination were strictly recorded. The possible adverse hormonal reactions such as hyperglycemia, hypertension and gastrointestinal ulcer bleeding should be closely monitored and appropriate treatment measures should be taken in time. Subject will be allowed to terminate the test if necessary. Record and discuss similar events. The double blind principle is strictly observed during the experiment to ensure the authenticity and reliability of the experimental data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Prednisolone, oral, 2 mg/kg.d (maximum dose 60 mg/day), two or three times a day , 5 days. |
|
| Placebo group | Placebo Comparator | The same amount of placebo was taken orally as the trial for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone Acetate | Drug | The experimental group took prednisolone acetate which is a kind of oral glucocorticoid. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the rate of early treatment success | temperature is normal, clinical manifestations are significantly improved, pulmonary signs are significantly improved or disappeared, and white blood cell\C reactive protein\procalcitonin returns to normal | third day |
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Inclusion Criteria:
1 month-< 18 years old.
Clinical diagnosis of community-acquired pneumonia (fever, cough, sputum, chest pain, dyspnea, abnormal breath sounds in the lungs, imaging pneumonia changes).
Meet any of the following:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Baoping Xu | Contact | 13370115002 | xubaopingbch@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Baoping Xu | Beijing Children's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baoding Children's Hospital | Recruiting | Baoding | China |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C009935 | prednisolone acetate |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| placebo | Other | A placebo consistent in appearance with the prednisolone acetate. |
|
| Beijing Children's Hospital | Recruiting | Beijing | China |
|
| Beijing Fangshan District Health Care Hospital | Recruiting | Beijing | China |
|
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |