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IRCT20220225054120N1 IRCT 2022-05-11 Ilam University of Medical Sciences Evaluation of the effect of comparing bronchodilators with corticosteroids and bronchodilators in children with bronchiolitis Evaluation of the effect of comparing bronchodilators with corticosteroids and bronchodilators in children with bronchiolitis 2022-05-07 anticipated 60 Complete https://irct.ir/trial/62207 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the first stage, the researcher uses the main entry and exit conditions of the study to prepare a list of eligible patients to participate in this study. If you wish and consent to participate in this research study, general information and written consent. Will be taken from patients' families. Then 60 patients with bronchiolitis are randomly divided into control group or intervention group using block randomization method by hiding random allocation. The control group will receive only the standard treatment protocol, but the intervention group will receive corticosteroids in addition to the standard treatment protocol, Blinding description: The patient receives the drug (intervention or comparison group) in sealed packets encoded. The coding is done by one of the project partners and the doctor, the evaluator and the patient are blind. 3 Bronchiolitis. Intervention group: The first group: hydrocortisone with Oxycort brand 5 mg per weight (one dose) and bronchodilator as ventolin or salbutamol at a dose of 0.15 mg per weight with an interval of 20 minutes, up to one hour in three times. / The second group only bronchodilator In the form of ventolin or salbutamol at a dose of 0.15 mg per weight at intervals of 20 minutes, up to one hour in three doses. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Zahra Maleki
East Azarbaijan province, Kalibar city, Moallem street, Valfajr alley 2, No. 672
Kaleibar Iran (Islamic Republic of) ۵۴۶۱۸۳۸۱۸۸ +98 41 4444 2476 z.maleki69@yahoo.com Ilam University of Medical Sciences scientific zahra maleki
East Azarbaijan province, Kalibar city, Moallem street, Valfajr alley 2, No. 672
Kaleibar Iran (Islamic Republic of) ۵۴۶۱۸۳۸۱۸۸ +98 41 4444 2476 z.maleki69@yahoo.com Ilam University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria Based on the standard definition of bronchiolitis, the first or second episode of respiratory distress with wheezing and clinical evidence of viral respiratory infection such as body temperature 38 ° C and above, tachypnea and tachycardia or Coryza symptoms. 2 months 24 months Both History of more than two episodes of respiratory distress in the past. Chronic heart and lung disease Immunodeficiency Down Syndrome Metabolic or neurological illness History of prematurity (less than 34 weeks of Gesteitional age) Use of mechanical ventilation in infancy Positive family history of utopia Ill child in need of hospitalization due to dehydration, decreased level of consciousness, lethargy or symptoms of respiratory failure J11.1 Influenza due to unidentified influenza virus with other respiratory manifestations Treatment - Drugs Intervention group: The first group: hydrocortisone with Oxycort brand 5 mg per weight (one dose) and bronchodilator as ventolin or salbutamol at a dose of 0.15 mg per weight with an interval of 20 minutes, up to one hour in three times. / The second group only bronchodilator In the form of ventolin or salbutamol at a dose of 0.15 mg per weight at intervals of 20 minutes, up to one hour in three doses All infants 2 to 24 months of age with the first Wise attack who are diagnosed with bronchiolitis need to be hospitalized and receive oxygen. Timepoint: After initial evaluation (on arrival), second evaluation (1 hour appointment) (1 dose of hydrocortisone ampoule, 5 mg per kg body weight and ventolin nebulizer at a dose of 0.15 mg per kg body weight (minimum dose) 2.5 mg and a maximum of 5 mg) and continue ventilation every 20 minutes for up to 3 doses, including monitoring of oxygen prevalence (using pulse oximetry), respiration rate, and pulse rate. In addition to oxygen saturation, Pulse rate and respiration rate, RDA Score and Clinical Score will also be checked and recorded. Method of measurement: CBSS table. Ilam University of Medical Sciences Approved 2022-01-08 Ethics Committee of Ilam University of Medical Sciences Ilam, Bangangab, Research Blvd., Ilam University of Medical Sciences, ilam Ilam Iran (Islamic Republic of)