Protocol summary

Study aim
The aim of this study is to comparison of efficacy of nebulized ventolin and pulmicort and normal saline in treatment of children under 2 years old with bronchiolitis.
Design
This is a controlled single-blinded clinical trial study will be conducted on 100 children with the diagnosis of bronchiolitis. After coordination and obtaining informed consent, the patients will be randomly assigned into 3 groups of ventolin, pulmicort and normal saline.
Settings and conduct
This single-blinded clinical trial study will be conducted in Aboozar Hospital, Ahvaz, Iran. The patients under the age of 24 months with the diagnosis of bronchiolitis will be randomly divided into 3 groups. In Group 1: patients received nebulized ventolin, in Group 2: the patients received pulmicort, and in Group 3: the patients received nebulized normal saline.
Participants/Inclusion and exclusion criteria
Inclusion criteria: children less than 24 months, definitive diagnosis of bronchiolitis, parents’ consent to participate in the study; Exclusion criteria: Chronic heart and lung disease (heart failure or pulmonary cyst), immunodeficiency, metabolic or neurological diorders, birth below 34 weeks, use of ventilator in neonatal period, receiving systemic corticosteroid or antibiotic during hospitalization.
Intervention groups
In first group, Ventolin nebulizer (Salbutamol) 0.15 mg/kg every 4 hours will be administered by nebulizer. In second group, Budesonide (Pulmicort) 125 mg 2 twice a day (morning and evening) will be administered. In third group, normal saline nebulizer (3 ml normal saline 0.9%) every 4 hours will be administered.
Main outcome variables
The Oxygen saturation, Symptom severity (clinical score) and length of recovery will be compared between the 3 groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200209046435N1
Registration date: 2020-03-11, 1398/12/21
Registration timing: prospective

Last update: 2020-03-11, 1398/12/21
Update count: 0
Registration date
2020-03-11, 1398/12/21
Registrant information
Name
Mahsa Abdolahzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3001 3374
Email address
abdolahzadeh.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-08-20, 1399/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of efficacy of nebulized Ventolin and Pulmicort and normal saline in treatment of children under 2 years old with bronchiolitis
Public title
The efficacy of Ventolin and Pulmicort and normal saline in treatment of bronchiolitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children less than 24 months, , Definitive diagnosis of bronchiolitis Parents’ consent to participate in the study
Exclusion criteria:
Chronic heart and lung disease (heart failure or pulmonary cyst) Immunodeficiency Metabolic or neurological diorders Birth below 34 weeks Use of ventilator in neonatal period Receiving systemic corticosteroid or antibiotic during hospitalization
Age
To 24 months old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned into three groups by simple randomization method. Allocation of patients to the study groups will be done by random-numbers table and using computer, and on this basis patients will be included in one of the three treatment groups before starting intervention. The implementation of the random allocation sequence occurs without knowledge of which patient will receive which treatment
Blinding (investigator's opinion)
Single blinded
Blinding description
Intervention (receiving normal saline or Ventolin or Pulmicort) and patient evaluation will be carried out by a physician who is aware of treatment groups. The patients parents and statistical analyzer will not know about patient grouping.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Approval date
2020-01-25, 1398/11/05
Ethics committee reference number
IR.AJUMS.REC.1398.807

Health conditions studied

1

Description of health condition studied
Bronchiolitis
ICD-10 code
J21
ICD-10 code description
Acute bronchiolitis

Primary outcomes

1

Description
Symptom severity (clinical score)
Timepoint
Everyday, before intervention and during the intervention
Method of measurement
According to Respiratory Distress Assessment Index (RDAI)

2

Description
Duration of symptom recovery
Timepoint
Daily, before intervention until the end of intervention
Method of measurement
Duration of recovery from wheezing and cough based on clinical examination

3

Description
Oxygen saturation
Timepoint
Every day, before intervention and during the intervention
Method of measurement
Using pulse oximeter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Ventolin nebulizer (Salbutamol) 0.15 mg/kg every 4 hours will be administered by nebulizer.
Category
Treatment - Drugs

2

Description
Intervention group: Budesonide (Pulmicort) 125 mg 2 twice a day (morning and evening) will be administered.
Category
Treatment - Drugs

3

Description
Control group: normal saline nebulizer (3 ml normal saline 0.9%) every 4 hours will be administered.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Aboozar Hospital
Full name of responsible person
Mahsa Abdollahzade
Street address
Aboozar Hospital, Tohid Blv., Zeytun Karmandi
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3444 9003
Email
mahsa2425@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3001 3374
Email
badavim@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Farhad Abolnezhadian
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Immunology
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3001 3374
Email
abolnezhadian-f@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Farhad Abolnezhadian
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Immunology
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3001 3374
Email
abolnezhadian-f@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahsa Abdolahzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3001 3374
Fax
Email
Abdolahzadeh.m@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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