- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03814954
Nebulized Epinephrine vs. Salbutamol in Bronchiolitis Among Children
Nebulized Epinephrine Versus Nebulized Salbutamol in Bronchiolitis Among Children Aged 1month-24months
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The objective of this study is to determine if nebulized epinephrine is more efficacious than nebulized salbutamol in all hospitalized children (1 month to 24 months) in treatment of bronchiolitis. A randomized clinical trial which recruits children admitted to the pediatrics department with diagnosis of bronchiolitis. Children aged 1 month to 2 years will be included in the study.
Children who meet the inclusion criteria will be alternately distributed in two groups:
Group 1:
Will receive salbutamol (2 units/kg) with 3 ml normal saline by nebulizer.
Group 2:
Will receive epinephrine (0.5 mg/dose) with 3 ml normal saline by nebulizer. All admitted patients will receive aerosol every 20 minutes three times and after, depending on the clinical status of the patients, they will be given oxygen therapy at 1.5 liters / minute at the admission if oxygen saturation is below 94% till the normalization of the oxygen saturation.
Clinical parameters such as clinical score, oxygen saturation with pulse oximetry, heart rate, and temperature will be measured at admission, at hour 1 to hour 12 and then every 24 hours until they are discharged.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Beirut, Lebanon
- Makassed General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children diagnosed with acute bronchiolitis.
Exclusion Criteria:
- Children with congenital heart disease or
- chronic lung diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Salbutamol
Patients will receive salbutamol (2 units/kg) with 3 ml normal saline by nebulizer.
|
At first day of admission, patients will receive 3 doses of nebulized salbutamol every 20 minutes.
Then after 24 hours patients will receive standing dose according to clinical status
|
Experimental: Epinephrine
Patients will receive epinephrine (0.5 mg/dose) with 3 ml normal saline by nebulizer.
|
At first day of admission, patients will receive 3 doses of nebulized epinephrine every 20 minutes.
Then after 24 hours patients will receive standing dose according to clinical status
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of stay
Time Frame: 5 days
|
Patients hospitalization duration will be recorded
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory distress scoring
Time Frame: 5 days
|
The score will be measured through Silverman-Andersen Retraction scoring.
The minimum score is 0 indicating no distress.
The maximum score is 10 indicating severe respiratory distress
|
5 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mariam Rajab, MD, Makassed General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Bronchial Diseases
- Lung Diseases, Obstructive
- Bronchitis
- Bronchiolitis
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Albuterol
- Epinephrine
Other Study ID Numbers
- 1812182
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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