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IRCT20200721048155N1 IRCT 2020-08-01 Mashhad University of Medical Sciences The effect of low-dose hydrocortisone on neonatal respiratory status under mechanical ventilation Investigation of the effect of low-dose hydrocortisone on neonatal respiratory status under mechanical ventilation 2020-02-05 anticipated 30 Complete https://irct.ir/trial/49795 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two groups, Blinding description: In this study, participants as well as the person who assigns them to the two groups are not aware of the type of treatment and the intervention. 2-3 respiratory status under mechanical ventilation. Intervention 1: Intervention group: In this group, Intravenous dexamethasone 24 hours before until 48 hours after extubation with the dose of 0.5 mg/kg /day will be administered. In addition, hydrocortisone will be used for 5 days where in the first 3 days, it is administered twice daily with the dose of 0.5 mg/kg and in the next 2 days, once daily with the dose of 0.5 mg/kg. During the intervention, the neonate's blood pressure is controlled 3 times each 24 hours and the blood sugar is checked twice a day using glucometer. Intervention 2: Control group: In this group, the common method will be used. Intravenous dexamethasone 24 hours before until 48 hours after extubation with the dose of 0.5 mg/kg /day will be administered. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published. To whom: Data will be available for researchers in universities and other scientific institutes. Conditions: Carrying out analysis on data is permitted. Where to obtain: Data can be accessible through an email to the corresponding author. How to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. Comments:
public Raheleh Faramarzi Garmroudi
Ahmad Abad Av, Ghaem hospital
Mashhad Iran (Islamic Republic of) 9176999311 +98 51 3801 2496 faramarzigr@mums.ac.ir Mashhad University of Medical Sciences scientific Raheleh Faramarzi Garmroudi
Ahmad Abad Av, Ghaem hospital
Mashhad Iran (Islamic Republic of) 9176999311 +98 51 3801 2496 faramarzigr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Preterm neonates who have been under mechanical ventilation for at least 14 days Informed consent of the patient's legal guardian 7 days 30 days Both Heart patients with failure Observable irregularities Neuromuscular diseases which influence respiratory effort P27.8 Other chronic respiratory diseases originating in the perinatal period Treatment - Drugs Treatment - Drugs Intervention group: In this group, Intravenous dexamethasone 24 hours before until 48 hours after extubation with the dose of 0.5 mg/kg /day will be administered. In addition, hydrocortisone will be used for 5 days where in the first 3 days, it is administered twice daily with the dose of 0.5 mg/kg and in the next 2 days, once daily with the dose of 0.5 mg/kg. During the intervention, the neonate's blood pressure is controlled 3 times each 24 hours and the blood sugar is checked twice a day using glucometer. Control group: In this group, the common method will be used. Intravenous dexamethasone 24 hours before until 48 hours after extubation with the dose of 0.5 mg/kg /day will be administered. Status of need for mechanical ventilation based on level of oxygen needed. Timepoint: Before and during intervention and after disconnection from ventilation. Method of measurement: Patient monitoring device. Duration of connection to the ventilation device. Timepoint: Before intervention. Method of measurement: Counting the number of days patient was connected to the ventilation device. Mashhad University of Medical Sciences Approved 2020-02-04 Ethic Committee of Mashhad University of Medical Sciences Ghoreyshi Building, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)