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IRCT20190503043457N1 IRCT 2019-05-28 Vice chancellor for research and technology, Qom university of medical sciences Comparison of inhaled salbutamol with placebo (water for inj.) on recovery process of newborns' transient tachypnea Comparison of inhaled salbutamol With placebo (water for inj.) as an add-therapies on the duration of stay of newborns and the Recovery process of tachypnea and o2 dependence in transient tachypnea of Newborns in NICU in Qom hospitals: a clinical trial study 2018-03-21 anticipated 60 Complete https://irct.ir/trial/39273 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A random block allocation method will be used. In this way, 11 blocks of four will be considered. Then, using the random number table for each block, one of the following conditions will be considered: AABB, ABAB, ABBA, BBAA, BABA, BAAB, Blinding description: Doctors and nurses and participants do not know who is in which group. 3 Transient tachypnea of Newborns. Intervention 1: Intervention group: Receiving Salbutamol at a dose of 0.15 mg/kg body weight in 4 cc normal saline by nebulizer for 10 minutes. Intervention 2: Control group: Receiving four cc distilled water by 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 No more information
public Mohammad mahmoudi
Masoumeh Children Hospital ,Imam khomeini St.
Qom Iran (Islamic Republic of) 0000000000 +98 25 3665 1801 u.hedayati@gmil.com Ghoum University of Medical Sciences scientific Alireza saadati
Masoumeh Children Hospital, Imam Khomeini st.
Qom Iran (Islamic Republic of) 0000000000 +98 25 3665 1801 a.rsaadati@muq.ac.ir Ghoum University of Medical Sciences Iran (Islamic Republic of) A healthy term newborn with mild to moderate respiratory distress 1 day 7 days Both Multiple anomalies Severe infection Metabolic disease P22.1 Transient tachypnoea of newborn Treatment - Drugs Placebo Intervention group: Receiving Salbutamol at a dose of 0.15 mg/kg body weight in 4 cc normal saline by nebulizer for 10 minutes Control group: Receiving four cc distilled water by nebulizer for 10 minutes Number of breaths. Timepoint: 30 minutes, one and four hours after treat. Method of measurement: By physician based on the number of breaths per minute. Percent saturation of oxygen. Timepoint: 30 minutes, one and four hours after treat. Method of measurement: By pulse oximetry. Heart rate. Timepoint: 30 minutes, one and four hours after treat. Method of measurement: By pulse oximetry. Vice chancellor for research and technology, Qom university of medical sciences Approved 2019-03-05 Ethics Committee of Qom University of Medical Sciences No 83, alley 4, safashahr St. Qom Ghoum Iran (Islamic Republic of)