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IRCT20220806055625N2 IRCT 2022-12-26 Sanandaj University of Medical Sciences Investigating the effect of vitamin E on the Treatment of Neonatal Hyperbilirubinemia Comparison of the Effect of vitamin E Supplementation on the Treatment of Neonates with Hyperbilirubinemia: A Double-blind Randomized Clinical Trial 2022-12-01 anticipated 70 Complete https://irct.ir/trial/67135 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Neonates will be completely randomly assigned to two groups receiving vitamin E and placebo (10% Dextrose serum). To perform randomization, Excel software is used with the Random between command. To carry out this process, a two-digit code is assigned to each of the people entered into the study, and then using the software, these numbers are randomly selected to enter each of the groups. Odd or even numbers will be assigned to one group each, Blinding description: In this study, the design is double-blind; so that the neonates studied in two groups and their families and clinical caregivers are blinded to the intervention and intervention status. 3 Neonatal Hyperbilirubinemia. Intervention 1: Intervention group: 35 infants are placed in the group receiving vitamin E orally with a dose of 0/5 cc (equivalent to 10 drops) orally once a day, on the first, second and third days of the intervention. Intervention 2: Control group: 35 infants are placed in the group receiving 10% dextrose serum orally on the first, second and third days of the intervention. Dextrose serum in the amount of 0/5 cc orally once a day is administered to infants in the control 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 There is no further information
public Sirous Hematpour
NO.10, Pirooz alley, Jamejam Avenue
Sanandaj Iran (Islamic Republic of) 6618634683 +98 87 3322 9494 Dr.siroshematour@yahoo.com Sanandaj University of Medical Sciences scientific Sirous Hematpour
NO.10, Pirooz alley, Jamejam Avenue
Sanandaj Iran (Islamic Republic of) 6618634683 +98 87 3322 9494 Dr.siroshematour@yahoo.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Term infants with hyperbilirubinemia admitted to the neonatal department of Besat Sanandaj Hospital in 1401 Gestational age from 37 weeks to 42 weeks and 6 days Birth weight from 2500 Grams to 4000 Grams 1 day 30 days Both Evidence of infection Congenital malformation History of phenobarbital use in mother Hypothyroidism Inappropriate intrauterine growth Oral intolerance Mechanical ventilation P58 Neonatal jaundice due to other excessive hemolysis Treatment - Drugs Treatment - Drugs Intervention group: 35 infants are placed in the group receiving vitamin E orally with a dose of 0/5 cc (equivalent to 10 drops) orally once a day, on the first, second and third days of the intervention. Control group: 35 infants are placed in the group receiving 10% dextrose serum orally on the first, second and third days of the intervention. Dextrose serum in the amount of 0/5 cc orally once a day is administered to infants in the control group. Mean serum total bilirubin. Timepoint: Serum total bilirubin 24 hours, 48 hours and 72 hours after intervention in two groups. Method of measurement: Taking blood samples from the infants in the study at 24 hours, 48 hours and 72 hours after the intervention by a trained nurse and sending them to the lab. Mean serum indirect bilirubin. Timepoint: Serum indirect bilirubin 24 hours, 48 hours and 72 hours after intervention in two groups. Method of measurement: Taking blood samples from the infants in the study at 24 hours, 48 hours and 72 hours after the intervention by a trained nurse and sending them to the lab. The amount of changes in the mean serum total bilirubin. Timepoint: Before the intervention and 24, 48 and 72 hours after the intervention. Method of measurement: Comparing the average total serum bilirubin before the intervention and the average total serum bilirubin obtained 24, 48 and 72 hours after the intervention. The average number of hospitalization days of newborns in two groups. Timepoint: Number of hospitalization days 24 hours, 48 hours and 72 hours after intervention in two groups. Method of measurement: Registration the number of hospitalization days of the newborns according to the file by a trained nurse. The average hours of receiving phototherapy for newborns in two groups. Timepoint: Number of hours receiving phototherapy 24 hours, 48 hours and 72 hours after intervention in two groups. Method of measurement: Registering data of number of hours receiving phototherapy by a trained nurse. Possible complications of vitamin E drug. Timepoint: 24 hours, 48 hours and 72 hours after the intervention in two groups. Method of measurement: A booklet containing the desired questions related to possible complications (these complications are selected by reviewing the literature) is provided to the mothers of babies and is followed up by a trained nurse. Sanandaj University of Medical Sciences Approved 2022-03-12 Ethics committee of Kurdistan University of Medical Sciences Kurdistan University of Medical Sciences, Pasdaran Street Sanandaj Kurdistan Iran (Islamic Republic of)