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IRCT20221220056875N1 IRCT 2023-04-08 Arak University of Medical Sciences Investigating the effect of vitamin E in the prevention of kidney dysfunction in infants Evaluation of the effect of vitamin E in the prevention of acute renal failure in infants weighing more than 1000 admitted to the neonatal intensive care unit 2023-03-20 anticipated 150 Complete https://irct.ir/trial/67621 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization type will be simple randomization. 150 envelopes of the same shape and size with black and white inner beads will be selected. Then these 150 envelopes are mixed. When the patient visits according to the conditions of entering the study, the researcher will take out an envelope, and if the inner bead is black, the patient will enter the control group, and if the bead is white, the patient will enter the intervention group. This envelope will be stored in another box. This will be repeated 150 times, Blinding description: People from the research team who are responsible for nursing and prescribing drugs to patients will not know about the groups. Also after consent form approval, neither patients nor their companions were informed about patients group of control and intervention. Also in control group we will use placebo. 3 Acute kidney failure. Intervention 1: Intervention group: Vitamin E is prescribed at the dose of 3 units per kilogram of the baby's weight per day. This drug is manufactured by Behsa Company and is given to neonates for 6 days. Intervention 2: Control group: The same placebo will be used in this group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Najmeh Sadat Pishnamazi
Vice Chancellor for Education, Amir kabir Hospital, Arak, Iran
Tehran Iran (Islamic Republic of) 3819691187 +98 86 3222 2003 njmpishnamazi@gmail.com Arak University of Medical Sciences scientific Afsana Akhundzadeh
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
Tehran Iran (Islamic Republic of) 3819691187 +98 86 3222 2003 Afsanaakhundzadeh@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Hospitalized in the neonatal intensive care unit Weight more than 1000 grams Not having any congenital or chromosomal abnormalities no limit 30 days Both Allergy to vitamin E Contraindications for vitamin E use Lack of consent to participate in the study N17 Acute kidney failure Prevention Placebo Intervention group: Vitamin E is prescribed at the dose of 3 units per kilogram of the baby's weight per day. This drug is manufactured by Behsa Company and is given to neonates for 6 days. Control group: The same placebo will be used in this group. Creatinine. Timepoint: before the treatment and on the second, fourth and sixth days after starting the treatment. Method of measurement: Blood sampling is done from the patients and the creatinine level is determined by a laboratory kit. Arak University of Medical Sciences Approved 2023-01-14 Ethical Committee of Arak University of Medical Sciences Vice chancellor for research, Arak University of Medical Sciences, Basij Square, Arak, Iran Tehran Tehran Iran (Islamic Republic of)