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

This study is a double-blind parallel clinical trial in which60 infants are divided into control and intervention groups. To evaluate the effect of inhaled epinephrine on the success rate of extubation of intubated neonates over 3 days

This study was performed on 60 neonates with intubation for more than 3 days. Immediately after extubation, half a cc of epinephrine 1/10000 or distilled water is used every three hours, which is reduced to 72 times. Using a ver.1.1 Random number generator, a list of random numbers will be generated. It is a double-blind study.

The causes of premature infants and intubation are more than 3 days in the neonatal intensive care unit of Shariati Hospital in Tehran. Exclusion criteria are infants with chronic lung disease and chronic heart or nerve disease, and infants with genetic and syndromic diseases, as well as term infants over 34 weeks and weighing less than 1700 grams.

To evaluate the effect of inhaled epinephrine on the success rate of neonatal extubation, 112 intubated neonates over 3 days were randomly divided into two groups receiving inhaled epinephrine immediately after extubation or distilled water intake group. 0/5 cc L-Epinephrine 1/10000 were nebulized every three hours to 24 hours. Then reduce the frequency to 72 hours from the time it starts until it stops in 72 hours.

Vital signs (heart rate, blood pressure, and respiration rate), respiratory distress, and stridor after intubation, the number of re-intubations, the duration of intubation, and the length of time the infant was admitted to the ward are recorded in the records.

Due to the insufficient number of patients in the last 2 years, 60 patients were included in the study, 6 of whom died, and data analysis was performed on 54 infants.

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.

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.

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