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IRCT20210607051507N4 IRCT 2021-11-17 Tehran University of Medical Sciences To Investigate the Efficacy of Inhaled Epinephrine in Extubation of Preterm Neonates in Neonatal Intensive Care To Investigate the Efficacy of Inhaled Epinephrine in Extubation of Preterm Neonates in Neonatal Intensive Care 2021-11-22 anticipated 112 Complete https://irct.ir/trial/59549 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients were randomized into the two study groups of intervention with inhaled epinephrine or distilled water (placebo) with the method of shuffling a deck of cards named A or B placed in covered envelopes and block randomization designed in 15 blocks of 4 matched subjects (ABAB, AABB, ABBA BBAA, BAAB, BABA), got ready by one of the study persons who was not participating in the process of allocating of the agents or was not connected to patients or even the therapist. The final sample was randomly allocated into the two study arms with an equal size of 30 neonates, Blinding description: Because it is a double-blind clinical trial, a randomized list is provided to the pharmacist to produce a sequence that fits the drug packages so that it is identical in appearance and so on. The packages will then be given to the therapist. Appointment treatment will be given to patients according to the order of tablets from 1 to 60, which includes 30 syringes containing epinephrine for incense and 30 syringes containing distilled water for incense, which was done by the pharmacist according to a random list. After the pharmacist prepares the drugs, he will deliver them to the researcher and the researcher will provide them to the therapist. In this case, the therapist does not know which patient is receiving which treatment after randomization. 3 To Investigate the Efficacy of Inhaled Epinephrine in Extubation of Preterm Neonates in Neonatal Intensive Care. Intervention 1: Intervention group: 0.5 cc per kg L-epinephrine 1/10000 were used as every three hours to 24 hours. Then reduce the frequency to 72 hours from the time of onset to interruption in 72 hours. Intervention 2: Control group: Half a cc per kilogram of infant weight was distilled every three hours to 24 hours. Then reduce the frequency to 72 hours from the time of onset to interruption in 72 hours. No - There is not a plan to make this available Justification or reason for not sharing IPD is there is no further information
public Ameneh Lamsehchi
Central Organization of Tehran University of Medical Sciences, corner of Ghods Street, Keshavarz Boulevard,
Tehran Iran (Islamic Republic of) 81633125 +98 21 8163 3102 lamsehchila@gmail.com Tehran University of Medical Sciences scientific Setareh Sagheb
Shariati Hospital, Jalal Al-Ahmad Three Ways, North Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1411713135 00084901-021 dr.ssagheb@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Premature infants with intubation for more than 3 days in the neonatal intensive care unit of Shariati Hospital in Tehran no limit no limit Both Chronic lung disease Chronic heart disease nerve disease infants with a genetic and syndromic disease term infants over 34 weeks and weighing less than 1700 grams. T88.4 Failed or difficult intubation Treatment - Devices Treatment - Drugs Intervention group: 0.5 cc per kg L-epinephrine 1/10000 were used as every three hours to 24 hours. Then reduce the frequency to 72 hours from the time of onset to interruption in 72 hours Control group: Half a cc per kilogram of infant weight was distilled every three hours to 24 hours. Then reduce the frequency to 72 hours from the time of onset to interruption in 72 hours Pco2 in ABG. Timepoint: Six hours after extubation in the target group and placebo. Method of measurement: ABG. FIO2 percent. Timepoint: 24 hours after the start of epinephrine or stilled water after extubation. Method of measurement: Record of ventilator. High blood pressure. Timepoint: 24 hours after extubation. Method of measurement: Pressure control machine. Tachycardia (a heart rate above 180 beats per minute in the baby). Timepoint: 24 hours after extubation. Method of measurement: cardiac monitoring. Tachypnea ( the number of breaths above 60 per minute in the baby). Timepoint: 24 hours after extubation. Method of measurement: Counted by the nurse and recorded in the file. Surfactant requirement. Timepoint: During hospitalization. Method of measurement: Extraction from the patient file. Death. Timepoint: During hospitalization. Method of measurement: Extraction of patient file. Reintubation after extubation failure. Timepoint: During hospitalization. Method of measurement: Extract from the file. Intubation time. Timepoint: Hospitalization duration. Method of measurement: Extract from file. Duration of mechanical ventilation. Timepoint: Duration of mechanical ventilation. Method of measurement: Extract from file. The age of the baby at the time of intubation. Timepoint: The age of the baby at the time of intubation. Method of measurement: Extract of file. Gender of the baby. Timepoint: In hospitalization. Method of measurement: Extract from file. Gestational age. Timepoint: Hospitalization. Method of measurement: Extract from file. Duration of non-invasive mechanical ventilation such as NIPPV.NCPAP after extubation. Timepoint: After extubation. Method of measurement: Extract from file. Tehran University of Medical Sciences Approved 2021-09-23 Ethics Committee of Tehran University of Medical Sciences Room 605, sixth floor, corner of Ghods st.,Keshavarz Blvd., Tehran Tehran Tehran Iran (Islamic Republic of)