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IRCT20091201002801N6 IRCT 2023-07-23 Vice chancellor for research, Mazandaran University of Medical Sciences Comparison of Ventolin nebulizer with supportive treatment in Transient tachypnea of the newborns (TTN) admitted to the neonatal intensive care unit (NICU) of Imam Khomeini and Bouali Sari hospitals of Sari Comparison of Ventolin nebulizer with supportive treatment in Transient tachypnea of the newborns (TTN) admitted to the neonatal intensive care unit (NICU) of Imam Khomeini and Bouali Sari hospitals of Sari 2023-07-01 anticipated 60 Complete https://irct.ir/trial/71387 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Allocation of patients into two treatment groups will be by Stratified Permuted Block Randomization method with blocks of 4. First the patients are divided into two groups based on the severity of TTN, then in each group, using Block Randomization, the patients will receive one of the interventions. To generate random allocation, the sealed envelope site was used, which created the a random table with the code 105487821465911 for us, which shows how patients enter the two intervention groups, Blinding description: The nurse and the study participants do not know who is in which group. Placebo and drug have the same color and shape in appearance and are coded by the researcher and each patient will be given a drug code. Then the mediation is given to the nurse and nebulized. 3 Transient tachypnea of newborn. Intervention 1: Intervention group: In the intervention group, 0.1 mL of salbutamol (Ventolin, salbutamol sulfate 5 mg/mL) is nebulized in 3 mL of 0.9% normal saline. The standard dose of salbutamol is 0.15 mg/kg/dose. It will be nebulized every day with a jet-type nebulizer with a continuous oxygen flow of 5 liters per minute during a 10-minute period and every 6 hours for a day. Intervention 2: Control group: In the control group, they will receive 2 mL of 0.9% saline as a nebulizer. Yes - There is a plan to make this available What will be shared: Contact Dr. Roya Farhadi When: Informations will send within few days after the email. To whom: People working in academic institutions Conditions: Contact Dr. Roya Farhadi Where to obtain: Email How to obtain: Informations will send within few days after the email. Comments:
public Maedeh Gouran
ساری بلوار پاسداران بیمارستان بوعلی، مرکز تحقیقات عفونی اطفال
ساری Iran (Islamic Republic of) 4815838477 +98 11 3334 2334 maedeh.gooran@gmail.com Mazandaran University of Medical Sciences scientific Roya Farhadi
Booali hospital. Pasdaran Blvd
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 3018 rfarhadi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Neonates with gestational age more than 34 weeks Tachypnea with or without cyanosis Respiratory distress Chest X-ray findings in favor of TTN 1 year 30 days Both Meconium aspiration Other diseases in the radiography such as pneumonia and... Complex Coronary heart disease (CHD) Tachycardia above 180 Silverman Anderson score less than 46 Ventilator therapy since birth Diagnosis of RDS during hospitalization Administration of surfactant with diagnosis of RDS P22.1 Transient tachypnea of newborn Treatment - Drugs Placebo Intervention group: In the intervention group, 0.1 mL of salbutamol (Ventolin, salbutamol sulfate 5 mg/mL) is nebulized in 3 mL of 0.9% normal saline. The standard dose of salbutamol is 0.15 mg/kg/dose. It will be nebulized every day with a jet-type nebulizer with a continuous oxygen flow of 5 liters per minute during a 10-minute period and every 6 hours for a day Control group: In the control group, they will receive 2 mL of 0.9% saline as a nebulizer. Primary CPAP (continuous positive airway pressure) duration. Timepoint: Time interval from start to end of CPAP. Method of measurement: Minute and hour. Oxigen therapy duration. Timepoint: Time interval from start to end of Oxigen therapy. Method of measurement: Minute and hour. Hospitalization length. Timepoint: Time from hospitalization to discharge. Method of measurement: Day. Time to start feeding based on Silverman Anderson score less than 4. Timepoint: Time to start feeding in day. Method of measurement: Calendar. Stabilization of respiratory rate and heart rate. Timepoint: Calculate the stabilization time of respiratory rate and heart rate. Method of measurement: Hour. Vice chancellor for research, Mazandaran University of Medical Sciences Approved 2023-07-12 Ethics committee of Mazandaran University of Medical Sciences Vice chancellor for Research, Moallem square, Sari, Iran Sari Mazandaran Iran (Islamic Republic of)