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

NCT01065272 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-08-10

No results posted yet for this study

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.

Conditions

  • Bronchiolitis

Interventions

DRUG

Dexamethasone

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Hamad Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Khalid M Al-Ansari, FRCPC,FAAP · Hamad Medical Corporation, Weill Cornell Medical College, Doha-Qatar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Weeks
Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Qatar

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01065272 on ClinicalTrials.gov