Determination of the comparison therapeutic effect of 5% saline versus 3% in the hospitalized patient with Acute Bronchiolitis.
Design
The clinical trial with two groups (intervention and control), pragmatic, double-blind, randomized.
Settings and conduct
This study was conducted to evaluate the effect of 5% and 3% nebulizer saline in patients with acute bronchiolitis admitted to Heshmatiyeh Hospital in Sabzevar city. In this study, participants and those who evaluated the outcome in children were unaware of how children were grouped. Children are randomly assigned to the first intervention group (Nebulizer Saline 5%) and second intervention group (Nebulizer Saline 3%). The response to treatment is evaluated using MRAS (modified respiratory assessment score) at the beginning of the study (before the intervention) and daily until discharge.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children aged 1 to 24 months with moderate to severe Bronchiolitis and clinical scores >= 4
Exclusion criteria: The presence of underlying disease (cystic fibrosis, congenital heart disease, immune deficiency), Get antibiotics before studying, Get Cortisone Inhaled and Systemic Recent, Use of bronchodilators, History of immaturity and gestational age less than 32 weeks, Chronic pulmonary disease, and History of NICU admission
Intervention groups
First intervention group: Patients in this group received 0.15 mg/kg Salbutamol and 5 cc nebulizer saline 5% and 8 liters of oxygen per minute while receiving nebulizers.
Second intervention group: Patients in this group received 0.15 mg/kg Salbutamol and 5 cc nebulizer saline 3% and 8 liters of oxygen per minute while receiving nebulizers.
Main outcome variables
Determine the Modified Respiratory Assessment Score (MRAS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181006041252N4
Registration date:2018-12-31, 1397/10/10
Registration timing:registered_while_recruiting
Last update:2018-12-31, 1397/10/10
Update count:0
Registration date
2018-12-31, 1397/10/10
Registrant information
Name
Mohammad Sahebkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 8337
Email address
sahebkarm@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-26, 1397/10/05
Expected recruitment end date
2019-02-24, 1397/12/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the comparison therapeutic effect of 5% saline versus 3% in the hospitalized patient with Acute Bronchiolitis.
Public title
Investigating the comparison therapeutic effect of 5% saline versus 3% in the hospitalized patient with Acute Bronchiolitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 1 to 24 months with moderate to severe Bronchiolitis and clinical scores >= 4
Exclusion criteria:
The presence of underlying disease (cystic fibrosis, congenital heart disease, immune deficiency)
Get antibiotics before studying
Get Cortisone Inhaled and Systemic
Recent use of bronchodilators
History of immaturity and gestational age less than 32 weeks
Chronic pulmonary disease
History of NICU admission
Age
From 1 month old to 24 months old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was conducted based on a permutation block, Accordingly, 47 blocks were allocated to patients, in each block, 2 were from following groups, treatment group A and group B. Eventually, after completing the blocks, Group A and B were treated with Nebulizer Saline 5% and Nebulizer Saline 3%, respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
Each person will be assigned a study code A and B, which will only be known to the researcher of the type of groups. The person evaluating the outcome and the participants are unaware of the groups. It should be noted that saline 5% and 3% are similar in terms of appearance, color, and packaging.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences, Tohid Blvd, Sabzevar city
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2018-12-17, 1397/09/26
Ethics committee reference number
IR.MEDSAB.REC.1397.077
Health conditions studied
1
Description of health condition studied
Acute Bronchiolitis
ICD-10 code
J21
ICD-10 code description
Acute Bronchiolitis
Primary outcomes
1
Description
Determine the Modified Respiratory Assessment Score (MRAS)
Timepoint
At the beginning of the study (before the intervention) and daily until discharge
Method of measurement
Using the modified respiratory assessment score
Secondary outcomes
1
Description
Determine the respiratory sounds (Vising)
Timepoint
At the beginning of the study (before the intervention) and daily until discharge
Method of measurement
Auscultation of the lungs with Stethoscope
2
Description
Respiratory Rate
Timepoint
At the beginning of the study (before the intervention) and daily until discharge
Method of measurement
The number of chest or abdominal cramps in 15 seconds or 1 minute
3
Description
Determine the level of peripheral capillary oxygen saturation (SPO2)
Timepoint
At the beginning of the study (before the intervention) and daily until discharge
Method of measurement
Pulse Oximeter or Oxygenometer
Intervention groups
1
Description
ّIntervention group: Patients in this group received 0.15 mg/kg Salbutamol and 5 cc nebulizer saline 5% and 8 liters of oxygen per minute while receiving nebulizers.
Category
Treatment - Drugs
2
Description
ّIntervention group: Patients in this group received 0.15 mg/kg Salbutamol and 5 cc nebulizer saline 3% and 8 liters of oxygen per minute while receiving nebulizers.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmatiyeh hospital
Full name of responsible person
Nasrin Amini Fard
Street address
Heshamatiyeh Hospital, Asadabady Ave., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1014
Email
aminifardnasrin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Fereshte Ghorat
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8319
Email
Drghorat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Alireza Asadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1604
Email
dralirezaasadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Alireza Asadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1604
Email
dralirezaasadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Nasrin Amini Fard
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8337
Email
aminifardnasrin@gmail.com
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
Not applicable
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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available