Dexamethasone Versus Placebo in the Treatment of Viral Bronchiolitis in Patients With Either Eczema and or Parental or Sibling History of Asthma.A Randomized Controlled Trial.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Patients diagnosed as bronchiolitis were discharged at 12 hours for each group
研究概览
简要总结
The investigators hypothesized that oral Dexamethasone in addition to nebulized Salbutamol will improve the Bronchiolitis Clinical Severity Score,duration of treatment in the short stay unit,need for hospitalization and readmissions to the pediatric emergency in a subgroup of patients diagnosed as Bronchiolitis with either eczema and or a parental or sibling history of Asthma.
Two groups randomized will be given Nebulized Ventolin plus either oral Dexamethasone or placebo for 5 days.
Bronchiolitis severity score plus vital signs will be recorded regularly until patient is fit for discharge.
Patients will be discharged on Ventolin inhaler and to complete the five days course of oral Dexamethasone Patients will be followed up for 7 days post discharge by telephone.
详细描述
This is a prospective, randomized, double blinded controlled study. It will be conducted in the main Pediatric Emergency Centre in Qatar(Al- Saad),during the period of Jan 2010 - April 2012.
The study has been approval by the Institution Research Board. The sample size will be 200 patients.100 patients in each arm.
Patients triaged as moderate to severe bronchiolitis will be evaluated and eligible patients are admitted to short stay unit and managed as usual. History and full physical examination will be done by the attending physician and the nurse will check 02 sat., respiratory rate and pulse rate.
The Bronchiolitis clinical severity score will be assessed and then guardians of eligible patients will be approached explaining the purpose and treatment modalities.
Patients will be included after obtaining a verbal and written consent. A CXR and an RSV test will be done for all study patients upon recruitment. The attending physician will complete the data collection sheet A computer generated randomization code will be prepared by the statistician. A pharmacist will prepare the study medications and the placebo. Patients will be randomized to either one of the two treatments:- Ventolin-Dexamethasone group: Oral Dexamethasone 1mg/kg will be given for the first day and then 0.6mg/kg for the next 4 days in addition to the Ventolin nebulizations.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Weeks 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant's ≥ 4weeks and ≤ 18 month.
- •First time wheezers.
- •Bronchiolitis clinical severity score ≥
- •History of eczema in the patient.
- •Parenteral history of asthma
- •Sibling history of asthma
排除标准
- •Prematurity (Gestational age 34 weeks or less).
- •Previous history of wheezing episode.
- •Use of steroids within the last 48 hours.
- •Critically ill patients with one or more of the following:
- •Obtunded consciousness,
- •Progressive respiratory failure requiring PICU admission.
- •History of apnea.
- •Oxygen saturation less than 85%.
- •Chronic lung disease of prematurity.
- •Cystic fibrosis.
- •Congenital heart disease.
- •Immunodeficiency.
- •Exposure to Varicella within 21 days before enrollment.
研究组 & 干预措施
Ventolin - Dexamethasone group
Ventolin nebulization with normal saline is given at 0,30,60,120 and 180 minutes,then every 2 hourly. Oral Dexamethasone is also given daily for 5 days.
干预措施: Dexamethasone (Drug)
Ventolin - Placebo group
Ventolin nebulization with normal saline is given at 0,30,60,120 and 180 minutes,then every 2 hourly. Oral Placebo is also given daily for 5 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Patients diagnosed as bronchiolitis were discharged at 12 hours for each group
时间窗: 12 hours
次要结局
- Patients diagnosed as bronchiolitis were discharged at 18, 24 , 36 and 48 hours for each group(48 hours)