Protocol summary

Study aim
Evaluation of response to treatment and comparison of normal saline and hypertonic saline nebulizer in the bronchiolitis
Design
The design of the study is a randomized clinical trial. The randomization method is blocked. The sample size for each study group is 60.
Settings and conduct
All patients referred to the Ali Asghar Hospital, who suffered from bronchiolitis will be enrolled. Patients will be randomly divided into two groups based on 10 blocks. A total of 60 patients will be examined. Patients and data analyzer will be blind.
Participants/Inclusion and exclusion criteria
All patients referred to the Ali Asghar Hospital, who suffered from bronchiolitis will be enrolled. Inclusion criteria: patients over 1year, Clinical evidence of respiratory viral infection, Body temperature 38 degrees Celsius and above, Abnormal breathing rate based on age range, High heart rate due to age range, coryza. Exclusion criteria: Patients over 10 years old, History of more than two episodes of respiratory distress in the past, Chronic heart and pulmonary disease, Safety defect, Down syndrome, Metabolic or neurological disease Use of mechanical ventilation in neonatal period, Positive family history of asthma, Sick patient requiring immediate hospitalization due to dehydration, decreased consciousness, lethargy, or respiratory failure symptoms
Intervention groups
In control group Patients will receive 3 ml normal saline 0.9% each 20 minutes for 3 times and 8 liters of oxygen per minute via nebulizer. In intervention group Patients will receive 3 ml of hypertonic saline 3%, each 20 minutes for 3 times and 8 liters of oxygen per minute via nebulizer.
Main outcome variables
The number of pulses,The number of pulses, Breath rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151003024317N6
Registration date: 2019-08-19, 1398/05/28
Registration timing: prospective

Last update: 2019-08-19, 1398/05/28
Update count: 0
Registration date
2019-08-19, 1398/05/28
Registrant information
Name
Mahdi Rezai
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8868 6772
Email address
rezaei.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-16, 1398/06/25
Expected recruitment end date
2020-03-15, 1398/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of response to treatment and comparison of normal saline and hypertonic saline nebulizer in the bronchiolitis
Public title
Treatment of bronchiolitis
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical evidence of respiratory viral infection Body temperature 38 degrees Celsius and above Abnormal breathing rate based on age range High heart rate due to age range coryza Age over 1 year
Exclusion criteria:
History of more than two episodes of respiratory distress in the past, Chronic heart and pulmonary disease Safety defect Down syndrome Metabolic or neurological disease Use of mechanical ventilation in neonatal period Positive family history of asthma Sick patient requiring immediate hospitalization due to dehydration, decreased consciousness, lethargy, or respiratory failure symptoms Age over 10 years
Age
From 1 year old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups. In order to randomize, a random block method will be used. For this purpose, we formed blocks with 10 person. In each block, 5 individuals will be in intervention group and 5 will be in control group. A total of 6 blocks will be considered for sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Data will be analyzed by person who is blind to study groups, and patients will also be unaware of the type of treatment.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Shahid Hemmat highway, Tehran,Iran.
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-10-23, 1397/08/01
Ethics committee reference number
IR.IUMS.FMD.REC.1397.123

Health conditions studied

1

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

Primary outcomes

1

Description
Saturation of oxygen
Timepoint
On arrival, 10 minutes after the first nebulizer, 10 minutes after the second nebulizer; 10 minutes after the third nebulizer
Method of measurement
Pulse Oximetry

2

Description
The number of pulses
Timepoint
On arrival, 10 minutes after the first nebulizer, 10 minutes after the second nebulizer; 10 minutes after the third nebulizer
Method of measurement
Based on patient records

3

Description
Breath rate
Timepoint
On arrival, 10 minutes after the first nebulizer, 10 minutes after the second nebulizer; 10 minutes after the third nebulizer
Method of measurement
Based on patient records

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Patients will receive 3 ml normal saline 0.9% each 20 minutes for 3 times and 8 liters of oxygen per minute via nebulizer.
Category
Treatment - Drugs

2

Description
Intervention group: Patients will receive 3 ml of hypertonic saline 3%, each 20 minutes for 3 times and 8 liters of oxygen per minute via nebulizer.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali Asghar Hospital
Full name of responsible person
Samane Sadat Khoobbin Khoshnazar
Street address
Ali Asghar Children's Hospital, Shaheed Dastgerdi Street (Zafar),
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2042
Email
aach@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakooti
Street address
Shahid Hemmat highway, Tehran,Iran.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Samane Sadat Khoobbin Khoshnazar
Position
Emergency medicine specialist
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Hemmat highway, Tehran,Iran.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
Samanekhoshnazar@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyedeh Mahsa Mahmoudi Nejad Dezfuli
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Hemmat highway, Tehran,Iran.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
mahmoudinejad.m@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyedeh Mahsa Mahmoudi Nejad Dezfuli
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Hemmat highway, Tehran,Iran.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
mahmoudinejad.m@iums.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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