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IRCT20190328043133N1 IRCT 2023-03-12 Iran University of Medical Sciences The effect of inhaled salbutamol on treatment of Transient tachypnoea of newborn The comparison of inhaled salbutamol in two different doses and placebo on Transient tachypnoea of newborn 2022-11-22 anticipated 90 Complete https://irct.ir/trial/68303 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization list was obtained from https://www.sealedenvelope.com by the Block Randomization method. To prepare a random list, equal blocks of 6 are used so that the number of samples is the same in all three arms of the study. Babies are equally assigned to three groups A, B, and C with an equal number of patients, Blinding description: In the pharmaceutical company, the vials will be filled with salbutamol 1.25, 2.5 mg and normal saline 0.9% with the same volume and similar vials, and group A, B, and C labels will be placed on the vials. In this study, the only person who will know the content inside the vial is the neonatal specialist assistant. The neonatal specialist assistant has a role in allocating the randomized list and preparing raw materials, but will not have a role in the process of conducting the study directly and recording data. The NICU resident physician and nurse will be responsible for conducting the study and will not know the contents of the vials. 3 Transient tachypnoea of newborn. Intervention 1: Intervention group 1: In this group, infants receive inhaled salbutamol at a dose of 1.25 mg/kg through a nebulizer for 10 minutes. Intervention 2: Intervention group 2: In this group, infants receive inhaled salbutamol at a dose of 2.5 mg/kg of weight through a nebulizer for 10 minutes. Intervention 3: Control group: In this group, infants receive 0.9% normal saline through a nebulizer for 10 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 further information
public Farhad Abolhasan Choobdar
Aliasgar hospital; Zafar street
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2283 9368 choobdar.f@iums.ac.ir Iran University of Medical Sciences scientific Farhad Abolhasan Choobdar
Aliasgar hospital; Zafar street
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2283 9368 choobdar.f@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Consent of the infant's parents to participate in the study Minimum gestational age of 35 weeks Diagnosis of TTN is based on the criteria of respiratory distress less than 6 hours after birth (respiration rate more than 60 breaths per minute, grunting, nasal flaring or retraction, cyanosis) and known findings on X-ray (fluid in minor fissures, hyperventilation , prominent central vascular markings, flattening of the diaphragm, increased anterior-posterior diameter, bilateral perihilar congestion). Weight more than 2 kg 1 day 28 days Both Meconium aspiration Other known causes of tachypnea in infants such as (RDS, PPHN, pneumonia, meconium aspiration, premature sepsis of infants, polycythemia, hypocalcemia, hypoglycemia) Abnormal auscultation (Murmur) during cardiac examination Tachycardia (number of heart rate more than 180 per minute) or arrhythmia Asphyxia Incidence of drug drug reactions(tremor, hypoglycemia, hypokalemia, increase in blood pressure, tachycardia and arrhythmia) P22.1 Transient tachypnea of newborn Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: In this group, infants receive inhaled salbutamol at a dose of 1.25 mg/kg through a nebulizer for 10 minutes. Intervention group 2: In this group, infants receive inhaled salbutamol at a dose of 2.5 mg/kg of weight through a nebulizer for 10 minutes. Control group: In this group, infants receive 0.9% normal saline through a nebulizer for 10 minutes Tachypnea duration. Timepoint: Before the intervention, 30 minutes, 60 minutes and 4 hours after the intervention. Method of measurement: using a watch. Iran university of Medical Sciences Approved 2022-11-12 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences; Next to the Milad Tower; Hemmat Highway Tehran Tehran Iran (Islamic Republic of)