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IRCT20141201020175N3 IRCT 2018-03-02 Vice-chancellor of research, Isfahan University of Medical Sciences Efficacy of hypertonic saline in acute bronchiolitis 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 2014-09-23 anticipated 120 Complete https://irct.ir/trial/17889 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 2-3 Acute bronchiolitis. Intervention 1: 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. Intervention 2: Intervention group: Nebulize of 4 mL hypertonic saline(3%) with 1.5 mL of epinephrine through the mouth mask with oxygen; every 4 hours. Intervention 3: Intervention group: Nebulize of 4 mL hypertonic saline(5%) with 1.5 mL of epinephrine through the mouth mask with oxygen; every 4 hours. Intervention 4: Intervention group: Nebulize of 4 mL hypertonic saline(7%) with 1.5 mL of epinephrine through the mouth mask with oxygen; every 4 hours. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There was an agreement between authors to decide about this after acception of article

public Dr. Mohsen Reisi

Imam Hossein hospital, Imam Khomeini street, Isfahan

Isfahan Iran (Islamic Republic of) 411381515737 +98 31 3629 5672 Mohsenreisi72@yahoo.com Vice-chancellor of research of Isfahan University of Medical Sciences scientific Dr. Mohsen Reisi

Imam Hossein hospital, Imam Khomeini street, Isfahan

Isfahan Iran (Islamic Republic of) 411381515737 +98 31 3629 5672 Mohsenreisi72@yahoo.com Child Growth and Development Research Center, Pediatric Pulmonology Department, Research Institute o Iran (Islamic Republic of) 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 1 month 2 years Both 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 J21 with bronchospasm Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs 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 Intervention group: Nebulize of 4 mL hypertonic saline(3%) with 1.5 mL of epinephrine through the mouth mask with oxygen; every 4 hours Intervention group: Nebulize of 4 mL hypertonic saline(5%) with 1.5 mL of epinephrine through the mouth mask with oxygen; every 4 hours Intervention group: Nebulize of 4 mL hypertonic saline(7%) with 1.5 mL of epinephrine through the mouth mask with oxygen; every 4 hours Bronchiolitis respiratory assessment score (BRAS). Timepoint: Before intervention and then every 4 hours. Method of measurement: Bronchiolitis respiratory assessment score (BRAS). Length of hospital stay. Timepoint: At discharge. Method of measurement: Patient record. Respiratory rate. Timepoint: Before intervention and then every 4 hour. Method of measurement: observation. Temperature. Timepoint: Before intervention and then every 4 hour. Method of measurement: Thermometer. Heart rate. Timepoint: Before intervention and then every 4 hour. Method of measurement: determining pulse rate by use a chronometer. O2 saturation. Timepoint: Before intervention and then every 4 hour. Method of measurement: pulse oximeter. Vice-chancellor of research, Isfahan University of Medical Sciences Approved 2015-11-22 Ethics committee of Isfahan University of Medical Sciences Isfahan university of medical science, Hezarjarib street, Azadi square Isfahan Isfehan Iran (Islamic Republic of)