Impact of the Administration of Systemic Glucocorticoids on Inflammatory Response and Clinical Evolution of Patients Diagnosed With Moderate- Severe Bronchiolitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 94
- 主要终点
- Change from Baseline in inflammatory response
研究概览
简要总结
The purpose of this study is to to demonstrate that a 7-day course of systemic glucocorticoids decreases the inflammatory activity of moderate or severe bronchiolitis in paediatric patients compared to the standard treatment. To evaluate the morbidity (regarding to the clinical course: Intensive Pediatric Unit Care unit (PICU) admission, mechanical ventilation, ionotropic support, nosocomial infection, rescue therapy for respiratory failure; duration of PICU stay and hospitalization; and exitus) between the treatment and the control groups.
详细描述
A Prospective, randomised, double blind and placebo controlled study. Patients assigned to experimental group (group 1) will receive iv methylprednisolone 2 mg/kg/day (in two divided doses) and/or oral prednisolone 2,5 mg/kg/day (in two divided doses) every 12 hours, during 7 days.
Patients assigned to control group (group 2) will receive iv/oral glucose 5% solution as placebo, at the same dose and time as the experimental group. A total of 50 (initially 39, but it was extended to 50 by Protocol Amendment) patients per group are recruited.
Bronchiolitis is the most common infection of the lower respiratory tract. It is defined as, the first episode of bronchospasm, dyspnea, expiratory difficulty, feed refusal, tachypnea greater than 50 rpm and radiological evidence of hyperinflation, in less than 24 months.
It is a very prevalent disease, Respiratory syncytial virus (RSV) infects 70% of children under one year and 100% of children under 2 years and generates a major health impact on epidemic period (especially from December to February) . It is the most frequent cause of hospitalization in children under one year during the winter and up to 10% of those admitted will need intensive care, of which up to 60% required intubation and mechanical ventilation. The estimated disease in healthy children, mortality ranges from 0.005% to 0.02%, while in hospitalized children becomes between 1% and 3%.
In recent years, there have been numerous studies, mainly in RSV bronchiolitis, to analyze the immunological basis of the disease, as discussed complex, in order to perform a prophylaxis and treatment of more optimal infection.
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
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study will recruit paediatric patients younger than one year old who require hospitalization for moderate-severe bronchiolitis according to the BRONCHIOLITIS SCORE of Sant Joan de Deu Hospital (HSJD)
排除标准
- •Patients of either gender under one year old with mild bronchiolitis.
- •Patients with bronchiolitis in which the principal symptom is apnoea.
- •Patients who have received corticotherapy before admission to hospital.
- •No consent from parents or tutors.
- •Patients with previous acquired or innate immunodepression.
- •Patients enrolled in other clinical trials.
研究组 & 干预措施
Glucocorticoids
methylprednisolone intravenous administration of 2mg/kg/day (divided in two doses) and/or oral prednisolone 2,5 mg/kg/day (in two divided doses) during 7 days.
Patients younger than 2 year, who required hospitalization, affected by moderate or severe bronchiolitis
干预措施: Glucocorticoids (Drug)
Placebo
will receive iv/oral glucose 5% solution as placebo of 2mg/kg/day and/or 2,5 mg/kg/day (divided in two doses) during 7 days.
Patients younger than 2 year, who required hospitalization, affected by moderate or severe bronchiolitis.
干预措施: Placebo (Other)
结局指标
主要结局
Change from Baseline in inflammatory response
时间窗: enrollment to one week treatment
inflammatory response evaluation of the first week of glucocorticoids treatment as assessed by multiple measurements aggregated to arrive at one reported value, which are: the bronchiolitis clinical severity Scale, pediatric mortality Risk scale (PRISM III), the Chest x-ray test, the nasopharyngeal aspiration and analytical exploration (at day 5-7)
Morbidity episodes
时间窗: 14 months
Morbidity assessment by multiple measurements aggregated to arrive at one reported value which are as follow: necessity of mechanical ventilation, inotropic, presence of nosocomial infection, rescue therapies if respiratory failure occur; days of admission to the Pediatric Intensive Care Unit and hospitalization, in both treatment and control groups
次要结局
- Number of Side effects estimate(14 months)