Clinical Trial: Dexamethasone in the Treatment of Bronchiolitis in Patients With Either Eczema and or Family History of Asthma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Tr
Brief Summary:
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.
Detailed Summary:
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.
Ventolin-Placebo group: Oral Placebo with a volume equivalent to that of Dexamethasone will be given for the first day and then for the next 4 days in addition to the Ventolin nebulizations.
Nebulized Ventolin 0.5ml in 2 ml Normal Saline will also be given at 0, 30, 60, 120 and 180 minut
Sponsor: Hamad Medical Corporation
Current Primary Outcome: Patients diagnosed as bronchiolitis were discharged at 12 hours for each group [ Time Frame: 12 hours ]
Original Primary Outcome: Would the use of oral Dexamethasone improve the clinical condition as reflected by the Bronchiolitis Clinical Severity Score. [ Time Frame: 48 hours ]
Current Secondary Outcome: Patients diagnosed as bronchiolitis were discharged at 18, 24 , 36 and 48 hours for each group [ Time Frame: 48 hours ]
Original Secondary Outcome: Would the use of oral Dexamethasone decrease the duration of hospitalization? [ Time Frame: 48 hours ]
Information By: Hamad Medical Corporation
Dates:
Date Received: January 12, 2010
Date Started: February 2010
Date Completion:
Last Updated: August 9, 2016
Last Verified: September 2012
