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IRCT2017062129336N3 IRCT 2017-07-22 Vice Chancellor research of Ahvaz Jundishapur University of Medical Sciences Influence of Inhaled Salbutamol on the Outcome of Transient Tachypnea of the Newborn the study of Inhaled Salbutamol Influence on the Outcome of Transient Tachypnea of the Newborn in the imam khomeini hospital 2015-03-06 anticipated 148 Complete https://irct.ir/trial/23610 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Transient tachypnoea of newborn. Intervention 1: Intervention group: Salbutamol was administered in the intervention group. The solution was administered as an inhaler and through a nebulizer jet with an oxygen flow rate of 6-5 liters per minute.The medication was taken at 20 minutes each intervention. If the respiratory distress continued and oxygen was needed, the salbutamol was prescribed every 6 hours, for 72 hours after starting treatment. The dose of Salbutamol was 0.15 mg / kg body weight. If patient needed ventilator during treatment, intervention was stopped. Intervention 2: Control group: Normal saline (placebo) was administered in the control group. The solution was administered as an inhaler and through a nebulizer jet with an oxygen flow rate of 6-5 liters per minute.The intervention was taken at 20 minutes each intervention. If the respiratory distress continued and oxygen was needed, the normal saline was prescribed every 6 hours, for 72 hours after starting treatment. If patient needed ventilator during treatment, intervention was stopped.
public Dr Arash Malakian
Ahvaz Jundishapur University of Medical Sciences
Ahvaz Iran (Islamic Republic of) +98 61 3221 6501 malakian-a@ajums.ac.ir Ahvaz Jundishapur University of Medical Sciences scientific Dr Arash Malakian
Ahvaz Jundishapur University of Medical Sciences
Ahvaz Iran (Islamic Republic of) +98 61 3221 6501 malakian-a@ajums.ac.ir Ahvaz Jundishapur University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Rawlings and Smith's criteria include: 1) Tachypnea (RR> 60) during the first 6 hours of birth 2) Continuity of tachypnea for at least 12 hours 3) The CXR view consists of at least one of the following: elevation of the central vessels of the lung, increasing the thickness of the lobes between the lobes due to fluid accumulation, congestion of the navel of both lungs, airy lung, ie flattening of the diaphragm or enlargement of the anterior posterior chest or both Exclusion criteria: 1) Neonates with congenital anomalies 2) Proven systemic infection (positive blood culture) 3) Meconium aspiration 4) Respiratory distress syndrome (based on the graph) 5) Intrauterine growth retardation 6) history of fetal distress, pneumonitis, congenital heart disease, DIC, multi organ failure, hypocalcemia, hypoglycemia and polycythemia 1 day 28 days Both P22.1 Transient tachypnoea of newborn Treatment - Drugs Placebo Intervention group: Salbutamol was administered in the intervention group. The solution was administered as an inhaler and through a nebulizer jet with an oxygen flow rate of 6-5 liters per minute.The medication was taken at 20 minutes each intervention. If the respiratory distress continued and oxygen was needed, the salbutamol was prescribed every 6 hours, for 72 hours after starting treatment. The dose of Salbutamol was 0.15 mg / kg body weight. If patient needed ventilator during treatment, intervention was stopped. Control group: Normal saline (placebo) was administered in the control group. The solution was administered as an inhaler and through a nebulizer jet with an oxygen flow rate of 6-5 liters per minute.The intervention was taken at 20 minutes each intervention. If the respiratory distress continued and oxygen was needed, the normal saline was prescribed every 6 hours, for 72 hours after starting treatment. If patient needed ventilator during treatment, intervention was stopped. Breathing rate. Timepoint: 30 min, 1 and 4 h after Intervention. Method of measurement: Number of breaths per minute. Heart beat. Timepoint: 30 min, 1 and 4 h after Intervention. Method of measurement: heart beat per minute. Fraction of inspired oxygen. Timepoint: 30 min, 1 and 4 h after Intervention. Method of measurement: FIO2 %. O2 saturation. Timepoint: 30 min, 1 and 4 h after Intervention. Method of measurement: Pulse oximetry. Glucose. Timepoint: 12 h after intervention. Method of measurement: blood test. Potassium. Timepoint: 12 h after intervention. Method of measurement: blood test. Arterial blood gas. Timepoint: 12 h after intervention. Method of measurement: blood test. Vice Chancellor research of Ahvaz Jundishapur University of Medical Sciences Approved 2015-02-21 Ahvaz Jundishaour University of Medical Sciences Khuzestan, Ahvaz, Golestan, Ahvaz Jundishaour University of Medical Sciences Ahvaz Iran (Islamic Republic of)