A randomized clinical trial to compare efficacy of nebulized hypertonic saline and normal saline in Length of hospital stay and severity score in children with acute bronchiolitis
Compaision the efficacy of nebulized hypertonic(3%, 5% and 7% ) saline with normal saline in infants hospitalized with acute bronchiolitis
Design
120 children with moderate to severe bronchiolitis randomly assigned into four groups to receive nebulized normal saline(group A), saline 3%(group B), saline 5% (group C) and saline 7% (group D).
Settings and conduct
The study was done in emergency department of children hospitals in Isfahan. For each patient a vial labeled with a code was selected by chance and no one( parents of the patient, evaluators, analyzator) knew about content of the vial.
Participants/Inclusion and exclusion criteria
Inclusion criteria: any infant from 1-24 months old with acute onset of respiratory distress and presence of wheezing on examination
Exclusion criteria: evidence of atopy; history of prematurity (birth before 34 weeks or equal to); history of wheezing; history of previous bronchodilators or glucocorticoids use; loss of consciousness; history of chronic heart, pulmonary, neurologic, oncologic and immunologic disease.severe respiratory distress; respiratory failure requiring intubation or ICU admission
Early discharge (less than 24 hours from admission) , need for intubation or ICU care in the course of disease
Intervention groups
infants with bronchiolitis treated with nebulized normal saline
infants with bronchiolitis treated with nebulized 3% saline
infants with bronchiolitis treated with nebulized 5% saline
infants with bronchiolitis treated with nebulized 7% saline
Main outcome variables
Length of hospital stay (as primary outcome) and the use of oxygen, temperature, oxygen saturation (SPO2), pulse rate (PR), respiratory rate (RR) and bronchiolitis severity score (BRAS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141201020175N3
Registration date:2018-03-02, 1396/12/11
Registration timing:retrospective
Last update:2018-03-02, 1396/12/11
Update count:0
Registration date
2018-03-02, 1396/12/11
Registrant information
Name
Mohsen Reisi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3625 3678
Email address
mohsenreisi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-06-05, 1394/03/15
Actual recruitment start date
2015-11-22, 1394/09/01
Actual recruitment end date
2016-06-04, 1395/03/15
Trial completion date
empty
Scientific title
A randomized clinical trial to compare efficacy of nebulized hypertonic saline and normal saline in Length of hospital stay and severity score in children with acute bronchiolitis
Public title
Efficacy of hypertonic saline in acute bronchiolitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
acute onset of respiratory distress
prodromal respiratory symptoms
presence of wheezing on examination
severity score (BRAS) equal five or more
infants 1-24 months old
Exclusion criteria:
history of atopy
history of prematurity (birth before 34 weeks or equal to)
history of wheezing
history of previous use of bronchodilators or glucocorticoids use
loss of consciousness
history of chronic heart, pulmonary, neurologic, oncologic and immunologic disease
Age
From 1 month old to 2 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Actual sample size reached:
127
Randomization (investigator's opinion)
Randomized
Randomization description
Random Allocation was done by using a computer-generated list of random numbers to identify 1 of 4 codes identifying 1 of 4 different 100-mL bags of sterilely prepared blinded study solution containing 7%, 5%, 3%, or 0.9% saline.
Blinding (investigator's opinion)
Triple blinded
Blinding description
All the vials containing normal saline and different degree of hypertonic saline were labeled by a number code and for each patient one code would be selected by chance for treatment. Non of the parents of the patients( patients are infants), health care providers, physicions evaluating BRAS score before and after intervention, data collectors and outcome assessors knows the density of the each vial.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan university of medical science, Hezarjarib street, Azadi square
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2015-11-22, 1394/09/01
Ethics committee reference number
IR.MUI.REC.1394.3.242
Health conditions studied
1
Description of health condition studied
Acute bronchiolitis
ICD-10 code
J21
ICD-10 code description
with bronchospasm
Primary outcomes
1
Description
Bronchiolitis respiratory assessment score (BRAS)
Timepoint
Before intervention and then every 4 hours
Method of measurement
Bronchiolitis respiratory assessment score (BRAS)
2
Description
length of hospital stay
Timepoint
At discharge
Method of measurement
Patient record
Secondary outcomes
1
Description
Respiratory rate
Timepoint
Before intervention and then every 4 hour
Method of measurement
observation
2
Description
Temperature
Timepoint
Before intervention and then every 4 hour
Method of measurement
Thermometer
3
Description
Heart rate
Timepoint
Before intervention and then every 4 hour
Method of measurement
determining pulse rate by use a chronometer
4
Description
O2 saturation
Timepoint
Before intervention and then every 4 hour
Method of measurement
pulse oximeter
Intervention groups
1
Description
Nebulize of 4 mL normal saline(0.9%) with 1.5 mL of epinephrine (1 /1000) through the mouth mask with 4 L / min oxygen; every 4 hours
Category
Treatment - Drugs
2
Description
Intervention group: Nebulize of 4 mL hypertonic saline(3%) with 1.5 mL of epinephrine through the mouth mask with oxygen; every 4 hours
Category
Treatment - Drugs
3
Description
Intervention group: Nebulize of 4 mL hypertonic saline(5%) with 1.5 mL of epinephrine through the mouth mask with oxygen; every 4 hours
Category
Treatment - Drugs
4
Description
Intervention group: Nebulize of 4 mL hypertonic saline(7%) with 1.5 mL of epinephrine through the mouth mask with oxygen; every 4 hours