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IRCT20221028056324N1 IRCT 2023-09-09 Tabriz University of Medical Sciences Effect of nebulized Salbutamol versus Epinephrine in treatment of transient tachypnea of neonates The effect of nebulized Salbutamol versus nebulized Epinephrine in treatment of transient tachypnea of neonates in neonatal intensive care unit 2023-09-01 anticipated 90 Complete https://irct.ir/trial/72076 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization of the study groups will be done using a sealed envelope. Patients will be evaluated in three groups including intervention group 1, intervention group 2 and control group. 90 envelopes in three groups of A, B or C will prepared (30 each) and sealed. Then when the patients arrive at the neonatal intensive care unit, the envelopes are opened by the nurse delivering the patient and The grouping will be written as A, B or C on the clinical file. Then, according to the desired group, the intervention will be prescribed for the patients, Blinding description: The specialist that evaluating the final effect of the intervention and possible complications as well as the person analyzing the data will be blinded to the type of intervention. 3 Transient Tachypnea of Neonates. Intervention 1: Intervention group 1: In the salbutamol group, salbutamol nebulizer will be prescribed with a dose of 0.15 mg per kilogram of body weight of infants. Intervention 2: Intervention group 2: In the epinephrine group, 0.5 ml per kilogram of the infants weight will be prescribed from a 1 mg/ml ampoule of epinephrine. Intervention 3: Control group: 2 ml of normal saline will be nebulized. Yes - There is a plan to make this available What will be shared: Study data is categorized and coded with no identifiable individuals. When: Access to study data after publication of the result is available in the journal. To whom: Anyone interested in using the data can access the study data. Conditions: Study data can be used for comparison with other results. Where to obtain: Refer to the study's scientific or public accountability person for data. Dear researchers can access the data in a limited and coded manner, after completing the project end and acceptance of the scientific article, by sending a data access request from the accredited research centers with coordination with the university research committee. How to obtain: Refer to the study's scientific or public accountability person for data. Dear researchers can access the data in a limited and coded manner, after completing the project end and acceptance of the scientific article, by sending a data access request from the accredited research centers with coordination with the university research committee. Comments:
public Nazila Khanzadeh
No.5, Pamchal Alley, Golha Blvd., Golshahr Street, Tabriz
Tabriz Iran (Islamic Republic of) 5155734332 +98 41 3386 0108 Lotfalinezhadm@gmail.com Tabriz University of Medical Sciences scientific Nazila Khanzadeh
No.5, Pamchal Alley, Golha Blvd., Golshahr Street, Tabriz
Tabriz Iran (Islamic Republic of) 5155734332 +98 41 3386 0108 Lotfalinezhadm@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Transient tachypnea of neonates Neonatal intensive care unit 1 day 30 days Both First minute apgar below 4 Respiratory distress syndrome caused by surfactant deficiency Congenital anomalies Syndromes of chromosomal disorders Congenital heart diseases Premature neonatal sepsis Meconium aspiration Infants with metabolic disorders P22.1 Transient tachypnea of newborn Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: In the salbutamol group, salbutamol nebulizer will be prescribed with a dose of 0.15 mg per kilogram of body weight of infants. Intervention group 2: In the epinephrine group, 0.5 ml per kilogram of the infants weight will be prescribed from a 1 mg/ml ampoule of epinephrine. Control group: 2 ml of normal saline will be nebulized. Oxygen saturation. Timepoint: Half an hour, one hour and four hours after nebulizer administration. Method of measurement: Noninvasive Pulse Oximeter. Heart rate. Timepoint: Half an hour, one hour and four hours after nebulizer administration. Method of measurement: Physical Examination. Respiratory rate. Timepoint: Half an hour, one hour and four hours after nebulizer administration. Method of measurement: Physical examination. Fraction of Inspired Oxygen. Timepoint: Half an hour, one hour and four hours after nebulizer administration. Method of measurement: Pulse Oximeter. Number of nebulizer administrations. Timepoint: During hospitalization in the neonatal intensive care unit, from admission to discharge. Method of measurement: The number of nebulizer administrations will be obtained by counting documented nebulization events in medical records and treatment charts. Duration of NCPAP respiratory support (days). Timepoint: The total duration of nasal continuous positive airway pressure (NCPAP) respiratory support, calculated from initiation to complete discontinuation, measured in days. Method of measurement: During hospitalization in the neonatal intensive care unit, from initiation of NCPAP until complete discontinuation. Time to first enteral feeding (hours). Timepoint: From birth until initiation of the first enteral feeding. Method of measurement: Calculated based on the recorded time of birth and the documented time of initiation of the first enteral feeding in medical records. Time to full enteral feeding (days). Timepoint: From birth until achievement of full enteral feeding. Method of measurement: Calculated based on the recorded time of birth and the documented time at which full enteral feeding was achieved in medical records. Duration of supplemental oxygen (days). Timepoint: During hospitalization, from initiation of oxygen therapy until complete discontinuation. Method of measurement: Calculated based on documented start and end times of oxygen therapy in the neonate’s medical records in days. Length of hospital stay (days). Timepoint: At the time of hospital discharge. Method of measurement: Days. Tabriz University of Medical Sciences Approved 2022-10-03 Ethics committee of Tabriz University of Medical Sciences Mardaniazar Hospital, Khavaran Town Tabriz East Azarbaijan Iran (Islamic Republic of)