Research on the Treatment of Severe Community-acquired Pneumonia in Children
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- the rate of early treatment success
研究概览
简要总结
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.
详细描述
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.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •(1) the general condition is very poor;
- •(2) refusal to eat or dehydration;
- •(3) Significantly increased respiratory rate (70 times/min > infants, 50 times/min for older children>);
- •(4) dyspnea (three concave sign, moaning, nasal flapping)
- •(5) hypoxemia (cyanosis, transcutaneous oxygen saturation< 92% (not oxygenated));
- •(6) Pulmonary infiltration≥ 2/3 lung or multilobar infiltration;
- •(7) There is a pleural effusion;
- •(8) Extrapulmonary complications
排除标准
- •Systemic corticosteroids have been used to treat pneumonia before admission.
- •Use systemic glucocorticoids within 3 months before admission.
- •Hospital-acquired pneumonia.
- •Children with history of tuberculosis, branch expansion, tumors, immune deficiency, congenital heart, chronic pulmonary heart disease, kidney disease, severe malnutrition, recurrent respiratory infections, congenital bronchopulmonary dysplasia (BPD) and other underlying diseases.
- •Unconscious, need endotracheal intubation, children admitted to ICU.
- •Those who are allergic to the drugs or their preparation components involved in the study.
- •Those with hormonal contraindications: hypertension, diabetes, active peptic ulcer, adrenal hyperfunction, corneal ulcer, increased intraocular pressure, severe psychosis.
- •There is a current infection that is difficult to control with antibacterial drugs.
- •Children who are participating in other clinical trials.
- •The investigator believes that it is not suitable to participate in the study.
研究组 & 干预措施
Experimental group
Prednisolone, oral, 2 mg/kg.d (maximum dose 60 mg/day), two or three times a day , 5 days.
干预措施: Prednisolone Acetate (Drug)
Placebo group
The same amount of placebo was taken orally as the trial for 5 days
干预措施: placebo (Other)
结局指标
主要结局
the rate of early treatment success
时间窗: third day
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
次要结局
未报告次要终点
研究者
Baoping XU
Professor
Beijing Children's Hospital