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IRCT20201101049210N1 IRCT 2020-11-22 Gorgan University of Medical Sciences Comparing the effects of nebulized salbutamol epinephrine and 5 hypertonic saline on lowering theseverity of symptoms in infant Comparison of the effect of salbutamol and inhaled epinephrine and 5% hypertonic saline on reducing the severity of symptoms and duration of hospitalization of infants with bronchiolitis 2020-11-25 anticipated 45 Complete https://irct.ir/trial/51980 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After obtaining informed consent from the parents of eligible infants, their allocation to each of the three groups receiving salbutamol inhaler (a), inhaler epinephrine (b) and saline recipient Inhalation hypertension (c) will occur randomly. For this purpose, the Randomizer Software will be used. based on the software output, the enterance sequence of participants will be written in advance by one of the members of the research team on cards with the letters a, b, and c and will be placed in sealed and numbered envelops. Once the eligibility of the infants is determined based on the inclusion and exclusion criteria, the numbers listed on the envelope will be determined in each of the groups.For example, for the first infant, envelope number 1 is opened and according to the letter in that group, the intervention will be specified and the desired intervention will be applied. Due to the fact that the sequence of entry of individuals by a person other than the person responsible for the intervention will be specified and placed in sealed envelopes, the process of entry of infants into each of the intervention groups will remain secret until the envelopes are opened, Blinding description: In this study, the infant's parents, the person responsible for the intervention, and the person evaluating the outcome of the intervention will be kept unaware of how people are placed in the groups. In this way, the process of entering the groups will be determined in advance by one of the members of the research team and will be placed in numbered envelopes in the package. For this reason, when the infant is found to be eligible according to the inclusion criteria, the person responsible for the intervention (first physician) and the parents will be unaware of the type of intervention received (three intervention groups).After obtaining the consent of one of the envelopes, the numbers will be opened in order, and only at this stage it will be determined in which group the child will be placed. It should be noted that in this study, infants will be visited by two independent physicians. The first physician after assigning the child to the groups to apply the intervention and the second physician 24 and 48 hours after the intervention to evaluate the response to treatment. For this reason, both the intervention practitioner and the physician are responsible for evaluating the outcome of the intervention (response to treatment) and are unaware of the allocation. 3 Acute bronchiolitis. Intervention 1: Recipients of inhaled salbutamol. Nebulizer treated with salbutamol 2.5 mg / kg every 4 hours via nebulizer and 48 to 24 hours after hospitalization. Intervention 2: Intervention group:Recipients of inhaled epinephrine via nebulizer at 0.5 mg / kg and 48 to 24 hours after hospitalization. Intervention 3: Intervention group: Recipients of inhaled hypertonic saline (5% Nacl) at 3 cc at 0, 30 and 60 minutes. 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 is no more information
public Seyed Ali Mosavikhosravi
Taleghani Medical Educational Center, Janbazan Ave
Gorgan Iran (Islamic Republic of) 4918668197 +98 17 3224 7622 dr.ali.m363@gmail.com Gorgan University of Medical Sciences scientific Lobat Shahkar
Taleghani Hospital Janbazan St
Gorgan Iran (Islamic Republic of) 4916668197 +98 17 3222 7720 Lobatshahkar@yahoo.com Gorgan University of Medical Sciences Iran (Islamic Republic of) pediatric respiratory severity score>=4 history of lower respiratory tract infections wheezing,cough,cyanosis,spo2<90, fever age 2-24 month 2 months 24 months Both drug reaction to salbutamol or epinephrine or hypertonic salin history of chronic cardiopulmonary disease preterm labor histroy of admision in age 0-2 month history of treatment with bronchodilator agents history of corticosteroid administration J21 Acute bronchiolitis Treatment - Drugs Treatment - Drugs Treatment - Drugs Recipients of inhaled salbutamol. Nebulizer treated with salbutamol 2.5 mg / kg every 4 hours via nebulizer and 48 to 24 hours after hospitalization Intervention group:Recipients of inhaled epinephrine via nebulizer at 0.5 mg / kg and 48 to 24 hours after hospitalization Intervention group: Recipients of inhaled hypertonic saline (5% Nacl) at 3 cc at 0, 30 and 60 minutes Primary Outcome: Clinical signs including severity of respiratory distress, wheezing, skin color, general mood, respiratory rate, body temperature, and lung murmur. Timepoint: Before the intervention and 24 and 48 hours after the intervention. Method of measurement: Based on the score obtained from the pediatric respiratory severity score and observation. The length of hospital stay is the number of days a patient receives medication, parenteral fluid, and oxygen for bronchiolitis. Timepoint: Once at the end of the treatment period. Method of measurement: Count the days the patient receives medication, parenteral fluid, and oxygen for bronchiolitis. Gorgan University of Medical Sciences Approved 2020-10-04 Ethics committee of Golestan University of Medical Sciences Hircan Blvd., at the beginning of Shast Kola Road, Falsafi Educational Campus of Golestan University of Medical Sciences Gorgan Golestan Iran (Islamic Republic of)