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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
Makassed General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Score

Eligibility Criteria

1 Month - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

First Posted
January 21, 2019
Last Updated
August 28, 2022
Sponsor
Makassed General Hospital
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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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