Dexamethasone in the Treatment of Bronchiolitis in Patients With Either Eczema and or Family History of Asthma
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional
Phase: Phase 1

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 description: 
      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
      minutes and then every 2hours.

      Bronchiolitis severity score and O2 saturation will be recorded at enrollment, then after 4,6
      and 12hours then every 12 hourly until discharged.

      To give additional Ventolin nebulization will be decided clinically as per the discretion of
      the treating physician and will be recorded.

      Nebulized epinephrine will not be used except if the patient is severely distressed.
      Nebulized Epinephrine 0.5 mg/kg (max 5mg/dose) mixed in 3ml normal saline will be allowed for
      severely distressed patients as an add on therapy given on PRN basis..

      Additional interventions such as Oxygen therapy, Intravenous fluids and PRN nebulized
      Epinephrine will be recorded as additional therapies.

      Patients fit for discharge will have their nebulization stopped & date, time documented.

      Physician will discharge patients based on clinical grounds as not needing supplemental
      oxygen,minimal or no chest recessions,minimal wheezing or crackles and feeding adequately
      Patients will be sent home on Ventolin inhaler 2 puffs q 4 hours for 48 hours Then 2 puffs
      every 4 hours when needed plus the study medication syrup to complete 5days course.

      Follow up for one-week post discharge by a phone call daily will be conducted and patients
      will be assessed in PEC when needed.
    

Intervention name(s): Dexamethasone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 ml Salbutamol in 2 ml normal saline is given at 0,30,60,120,180 minutes and then every 2 hourly till discharge.
1mg/kg of oral Dexamethasone with cherry flavour is also given in the first day, then 0.6 mg/kg/day for 4 days; 0.5 ml Salbutamol in 2 ml normal saline is given at 0,30,60,120,180 minutes and then every 2 hourly till discharge.
1mg/kg of oral Placebo is also given in the first day, then 0.6 mg/kg/day for 4 days
Other intervention name(s): Steroids; normal saline plus cherry flavour
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dexamethasone; Bronchiolitis