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IRCT2017061515835N5 IRCT 2017-10-14 Zanjan University of Medical Sciences The effect of Zinc on Hyperbilirubinemia of newborns The effect of Zinc on Hyperbilirubinemia of healthy and normal newborns, a clinical trial 2017-11-01 anticipated 112 Complete https://irct.ir/trial/14984 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization is done. Patients are randomly assigned to one of the two intervention and placebo groups. The randomization unit is individual. Random number table is used. The random number table contains numbers from 1 to 112 in and we will read these numbers from up to down and we will write the succession. Then we will give Zinc sulfate to numbers 1 to 56 and Placebo to numbers 57 to 112. Then for hiding the sequence we will use sealed, opaque envelopes. Every one who will enter our study will choose one envelope which has one number of the random number table in it and his group will be defined, Blinding description: drug packs are marked by the main investigator with two signs A or B. Medication packs are delivered to the care provider with signs A or B. The care provider and the participant are unaware of the contents of the A or B envelopes. After the end of the study, specific intervention of each patient would be explained to him. A contains zinc sulfate and B contains placebo. 3 Neonatal physiological jaundice. Intervention 1: Daily administration of 5 mg (2.5 ml) twice daily of 10 mg per 5 ml Zinc Sulfate syrup produced by Donya-ye-Behdasht company in case group until the newborn is admitted. Intervention 2: Daily administration of 2.5 ml twice daily placebo produced by Faculty of Pharmacy, Zanjan University of Medical Sciences in control group until the newborn is admitted. 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 Newborns parents don`t allow
public Dr. Parisa Khoshnevis Asl
Pediatrics department, Ayatollah Moussavi Hospital, Gavazang street, Zanjan, Iran
Zanjan Iran (Islamic Republic of) 4515613191 +98 243313328 khoshnevis@zums.ac.ir Zanjan University of Medical Sciences scientific Dr. Parisa Khoshnevis Asl
Pediatrics department, Ayatollah Moussavi Hospital, Gavazang street, Zanjan, Iran
Zanjan Iran (Islamic Republic of) 4515613191 +98 243313328 khoshnevis@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Term infants Breast-feeding Jaundice Photo-therapy Serum bilirubin 15-20 mg/dL Age 3 to 7 days Using no other drug 3 days 7 days Both Recent weight loss Infection Hemolytic disease Oral intolerance Congenital birth defects Gastrointestinal anomalies Parental dissatisfaction for participation in the study Need for ventilators Need for blood transfusion P59.9 Neonatal jaundice, unspecified Treatment - Drugs Placebo Daily administration of 5 mg (2.5 ml) twice daily of 10 mg per 5 ml Zinc Sulfate syrup produced by Donya-ye-Behdasht company in case group until the newborn is admitted Daily administration of 2.5 ml twice daily placebo produced by Faculty of Pharmacy, Zanjan University of Medical Sciences in control group until the newborn is admitted Serum total bilirubin in hospitalization days. Timepoint: One time measuring before prescribing of Zink and immediately after that daily measurment in three days. Method of measurement: Colorimetric method by Lathe and Ruthven. Hospitalization days. Timepoint: Patient's discharging day. Method of measurement: Computation the number of hospitalization days from admission to discharge. Zanjan University of Medical Sciences Approved 2017-06-06 Ethics commite of Zanjan University of Medical Sciences Zanjan University of Medical Sciences, Azadi square, Zanjan, Iran Zanjan Zanjan Iran (Islamic Republic of)