Nebulized Epinephrine vs. Salbutamol in Bronchiolitis Among Children
Primary Purpose
Respiratory Distress Score
Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Salbutamol
Epinephrine
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Distress Score
Eligibility Criteria
Inclusion Criteria:
- Children diagnosed with acute bronchiolitis.
Exclusion Criteria:
- Children with congenital heart disease or
- chronic lung diseases
Sites / Locations
- Makassed General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Salbutamol
Epinephrine
Arm Description
Patients will receive salbutamol (2 units/kg) with 3 ml normal saline by nebulizer.
Patients will receive epinephrine (0.5 mg/dose) with 3 ml normal saline by nebulizer.
Outcomes
Primary Outcome Measures
Length of stay
Patients hospitalization duration will be recorded
Secondary Outcome Measures
Respiratory distress scoring
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
Full Information
NCT ID
NCT03814954
First Posted
January 21, 2019
Last Updated
August 28, 2022
Sponsor
Makassed General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03814954
Brief Title
Nebulized Epinephrine vs. Salbutamol in Bronchiolitis Among Children
Official Title
Nebulized Epinephrine Versus Nebulized Salbutamol in Bronchiolitis Among Children Aged 1month-24months
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makassed General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Acute bronchiolitis, mostly secondary to infection due to Respiratory syncytial virus (RSV) is very common in infants under two years old. It is usually benign. However, the dyspnea it causes is a big concern for parents and this disease can take a severe form on certain particular ground thus constituting a frequent reason for hospitalization in pediatrics. Nebulized epinephrine showed more efficacy than nebulized salbutamol.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Score
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Salbutamol
Arm Type
Active Comparator
Arm Description
Patients will receive salbutamol (2 units/kg) with 3 ml normal saline by nebulizer.
Arm Title
Epinephrine
Arm Type
Experimental
Arm Description
Patients will receive epinephrine (0.5 mg/dose) with 3 ml normal saline by nebulizer.
Intervention Type
Drug
Intervention Name(s)
Salbutamol
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Intervention Description
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
Primary Outcome Measure Information:
Title
Length of stay
Description
Patients hospitalization duration will be recorded
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Respiratory distress scoring
Description
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
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children diagnosed with acute bronchiolitis.
Exclusion Criteria:
Children with congenital heart disease or
chronic lung diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariam Rajab, MD
Organizational Affiliation
Makassed General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Makassed General Hospital
City
Beirut
Country
Lebanon
12. IPD Sharing Statement
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Nebulized Epinephrine vs. Salbutamol in Bronchiolitis Among Children
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