]>
IRCT20130308012743N3 IRCT 2022-11-13 Mashhad University of Medical Sciences oral melatonin in the treatment of acute respiratory distress syndrome The effect of oral melatonin in the treatment of acute respiratory distress syndrome in neonates 2022-08-23 anticipated 74 Complete https://irct.ir/trial/65424 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The allocation of infants will be done using block methods. A random sequence will be generated using four blocks of sealedenvelope.com. The envelopes will be printed by the researcher after randomization and will be placed inside the envelopes and the envelope lids will be closed. Envelopes are numbered in random order. Then, we first explain the purpose of the study to the person and he / she will sign the informed consent and receive the intervention based on the envelope number and the order specified in it, Blinding description: In this double-blind study, two groups of people under study, who are infants, and the outcome evaluator were blinded to the way the study was conducted. 3 Distress syndrome of neonates. Intervention 1: Intervention group: The intervention group will include infants who, in addition to the standard treatment, will be treated with oral melatonin at a dose of 10 mg/kg per day for three days. Intervention 2: Control group: They will undergo standard treatment (surfactant therapy and respiratory support). Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentified When: data can be accessible 6 months after results are published To whom: Data can be accessible through an email to the corresponding author Conditions: data will be available for researchers in universities and other scientific institution Where to obtain: After sending a request email to the corresponding author data will be sent in 1 month How to obtain: Carrying out analysis on data is permitted Comments:
public Farnaz Mousavi
Imam Reza Hospital, Ibn Sina Ave, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3852 1121 dr.farnazmousavi@gmail.com Mashhad University of Medical Sciences scientific Farnaz mousavi
Imam Reza Hospital, Ibn Sina Ave
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3852 1121 dr.farnazmousavi@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Infants with respiratory distress syndrome with any grade of respiratory distress 1 day 30 days Both Neonatal sepsis Neonates with Respiratory distress disease other than RSD Neonates with cardiovascular diseases or diseases of the central nervous system Neonates with kidney failure P22.0 P22.0Respiratory distress syndrome of newborn Treatment - Drugs Treatment - Drugs Intervention group: The intervention group will include infants who, in addition to the standard treatment, will be treated with oral melatonin at a dose of 10 mg/kg per day for three days. Control group: They will undergo standard treatment (surfactant therapy and respiratory support). Pro-antioxidant. Timepoint: Laboratory examination is done on the first and third day of birth. Method of measurement: By measuring pro-antioxidant test. C-reactive protein factor (CRP). Timepoint: Laboratory examination is done on the first and third day of birth. Method of measurement: By measuring CRP. Respiratory distress score. Timepoint: Laboratory examination is done on the first and third day of birth. Method of measurement: By Measuring Respiratory distress score. Mashhad University of Medical Sciences Approved 2022-05-17 Ethics Connate of Mashhad University of Medical Sciences Qureshi Bul, Daneshgah Ave, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)