Dexamethasone in the Treatment of Bronchiolitis in Patients With Either Eczema and or Family History of Asthma

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamad Medical Corporation
• Treatments: Albuterol; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Infant's ≥ 4weeks and ≤ 18 month.

• First time wheezers.

• Bronchiolitis clinical severity score ≥ 4.

• History of eczema in the patient.

• Parenteral history of asthma

• Sibling history of asthma

Exclusion Criteria:

• 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.