Dexamethasone in the Treatment of Bronchiolitis in Patients With Either Eczema and or Family History of Asthma (#9105)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hamad Medical Corporation
ClinicalTrials.gov Identifier:
NCT01065272
First received: January 12, 2010
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Bronchiolitis
Drug: Dexamethasone
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Trial.

Resource links provided by NLM:


Further study details as provided by Hamad Medical Corporation:

Primary Outcome Measures:
  • Patients diagnosed as bronchiolitis were discharged at 12 hours for each group [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patients diagnosed as bronchiolitis were discharged at 18, 24 , 36 and 48 hours for each group [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: February 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ventolin - Dexamethasone group
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

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

Other Name: Steroids
Placebo Comparator: Ventolin - Placebo group
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

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 Name: normal saline plus cherry flavour

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.

  Eligibility

Ages Eligible for Study:   up to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065272

Locations
Qatar
Hamad Medical Corporation, Pediatric Emergency Center,Alsaad.
Doha, Qatar, 3050
Sponsors and Collaborators
Hamad Medical Corporation
Investigators
Principal Investigator: Khalid M Al-Ansari, FRCPC,FAAP Hamad Medical Corporation, Weill Cornell Medical College, Doha-Qatar
  More Information

No publications provided

Responsible Party: Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT01065272     History of Changes
Other Study ID Numbers: #9105/09, #9105/09
Study First Received: January 12, 2010
Last Updated: September 11, 2012
Health Authority: Qatar: Hamad Medical Corporation

Keywords provided by Hamad Medical Corporation:
Dexamethasone
Bronchiolitis

Additional relevant MeSH terms:
Bronchiolitis
Bronchial Diseases
Bronchitis
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014