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IRCT20151003024317N6 IRCT 2019-08-19 Iran University of Medical Sciences Treatment of bronchiolitis Evaluation of response to treatment and comparison of normal saline and hypertonic saline nebulizer in the bronchiolitis 2019-09-16 anticipated 60 Complete https://irct.ir/trial/41425 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, 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 description: Data will be analyzed by person who is blind to study groups, and patients will also be unaware of the type of treatment. N/A Bronchiolitis. Intervention 1: 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. Intervention 2: 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. 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 After completing the work and consulting with all the writers and executive agents, I will be decided.
public Samane Sadat Khoobbin Khoshnazar
Shahid Hemmat highway, Tehran,Iran.
Tehran Iran (Islamic Republic of) 1449614535 +98 21 86701 Samanekhoshnazar@gmail.com Iran University of Medical Sciences scientific Seyedeh Mahsa Mahmoudi Nejad Dezfuli
Shahid Hemmat highway, Tehran,Iran.
Tehran Iran (Islamic Republic of) 1449614535 +98 21 86701 mahmoudinejad.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 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 1 year 10 years Both 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 J21 Acute bronchiolitis Treatment - Drugs Treatment - Drugs 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. 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. 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. 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. 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. Iran University of Medical Sciences Approved 2018-10-23 Ethics committee of Iran University of Medical Sciences Shahid Hemmat highway, Tehran,Iran. Tehran Tehran Iran (Islamic Republic of)