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IRCT201711139014N201 IRCT 2017-11-15 Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences Effect of inhaler salbutamol versus placebo on treatment of neonatal transient tachypnea Effect of inhaler salbutamol versus placebo on treatment of neonatal transient tachypnea: a double blind randomized clinical trial 2017-11-21 anticipated 52 Complete https://irct.ir/trial/9639 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots. Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as triple blind. 2 Neonatal transient tachypnea. Intervention 1: Intervention group: 0.1 ml/kg salbutamol and 2 ml normal saline 0.9% plus 5 to 6 l/min oxygen for 20 min will be nebulized. Intervention 2: Control group: 2 ml normal saline 0.9% plus 5 to 6 l/min oxygen for 20 min will be nebulized.
public Dr Nishtman Sadeghi
Fatemieh Hospital, Pasdaran Ave.
Hamadan Iran (Islamic Republic of) +98 81 3828 3939 nishti_sadeghi@yahoo.com Fatemieh Hospital scientific Dr Behnaz Basiri
Fatemieh Hospital, Pasdaran Ave.
Hamadan Iran (Islamic Republic of) +98 81 3828 3939 b.basiri@umsha.ac.ir Fatemieh Hospital Iran (Islamic Republic of) Inclusion criteria: Age of 34 to 47 weeks; neonatal transient tachypnea. Exclusion criteria: Pneumothorax; maternal addiction; respiratory distress syndrome; meconium aspiration; pneumonia; sepsis; congenital heart disease; pulmonary hypertension. 8 months 11 months Both P22.1 Transient tachypnoea of newborn Treatment - Drugs Placebo Intervention group: 0.1 ml/kg salbutamol and 2 ml normal saline 0.9% plus 5 to 6 l/min oxygen for 20 min will be nebulized. Control group: 2 ml normal saline 0.9% plus 5 to 6 l/min oxygen for 20 min will be nebulized. Number of breathing. Timepoint: Before and 0.5, 1 and 4 hours after treatment. Method of measurement: By physical examination. TTN clinical score. Timepoint: Before and 0.5, 1 and 4 hours after treatment. Method of measurement: By physical examination. Arterial oxygen saturation. Timepoint: Before and 4 hours after treatment. Method of measurement: By checking arterial blood sample. Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences Approved 2017-11-04 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Iran (Islamic Republic of)