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

NCT01065272 | Completed Phase 1 DMC

• 1 other identifier: #9105/09
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis

Keywords

Dexamethasone; Bronchiolitis

Outcome Measures

Primary Outcomes (1)

• Patients diagnosed as bronchiolitis were discharged at 12 hours for each group

  12 hours

Secondary Outcomes (1)

• Patients diagnosed as bronchiolitis were discharged at 18, 24 , 36 and 48 hours for each group

  48 hours

Study Arms (2)

Ventolin - Dexamethasone group

ACTIVE COMPARATOR

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.

Drug: Dexamethasone

Ventolin - Placebo group

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Dexamethasone DRUG

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

Also known as: Steroids

Ventolin - Dexamethasone group

Placebo DRUG

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

Also known as: normal saline plus cherry flavour

Ventolin - Placebo group

Eligibility Criteria

• Age: 4 Weeks - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad Medical Corporation, Pediatric Emergency Center,Alsaad.

Doha, Baladīyat ad Dawḩah, 3050, Qatar

Location

MeSH Terms

Conditions

Bronchiolitis

Interventions

Dexamethasone; Steroids; Saline Solution

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Khalid M Al-Ansari, FRCPC,FAAP

  Hamad Medical Corporation, Weill Cornell Medical College, Doha-Qatar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: February 9, 2010
• Study Start: February 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 10, 2016

Record last verified: 2012-09

Locations

QA (1)