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IRCT20091201002801N4 IRCT 2019-06-15 Mazandaran University of Medical Sciences Effect of oral Ursodeoxycholic acid on indirect jaundice of glucose-6-phosphate dehydrogenase-deficient neonates Effect of oral Ursodeoxycholic acid with phototherapy on indirect hyperbilirubinemia in glucose-6-phosphate dehydrogenase-deficient neonates 2019-06-22 anticipated 120 Complete https://irct.ir/trial/39858 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization of individuals by use of table of random numbers, Blinding description: Neonatologist who will investigate the bilirubin level and will asses the outcome is blind about the study groups. N/A Neonatal jaundice. Intervention 1: Intervention group 1: Neonates receiving phototherapy and Ursodeoxycholic acid (10 mg / kg / day every 12 hours to 48 hours). Ursodeoxycholic acid is a 300 mg capsule manufactured by Kushan Pharma Co., Tehran with generic name of Ursobil is given to the neonate with a specific dose solutes in 2 cc of breast milk . Intervention 2: Intervention group 2: Neonates receiving phototherapy and Ursodeoxycholic acid (20 mg / kg / day every 12 hours to 48 hours). Ursodeoxycholic acid is a 300 mg capsule manufactured by Kushan Pharma Co., Tehran with generic name of Ursobil is given to the neonate with a specific dose solutes in 2 cc of breast milk . Intervention 3: Control group: Neonates receiving phototherapy and placebo (breast milk). Yes - There is a plan to make this available What will be shared: Part of the data will be shared. When: starting 6 months after publication To whom: Only available for people working in academic institutions Conditions: Getting written permission for any use of data Where to obtain: Sending message to Dr. Roya Farhadi by E-mail: dr.royafarhadi@gmail.com How to obtain: After E-mail, information is sent within a few days. Comments:
public Roya Farhadi
Booali hospital. Pasdaran Blvd
Sari Iran (Islamic Republic of) 4817844718 +98 11 3334 3018 rfarhadi@mazums.ac.ir Mazandaran University of Medical Sciences scientific Roya Farhadi
Booali hospital. Pasdaran Blvd
Sari Iran (Islamic Republic of) 4817844718 +98 11 3334 3018 rfarhadi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Exclusive breast fed neonates Neonates with age of 2-14 days Direct bilirubin less than 15% of total serum billirubin or less than 1.5 mg/dl Neonates weighing between 2500 to 4000 grams. Neonates with jaundice and glucose 6-phosphate dehydrogenase deficiency require admission and phototherapy. 2 days 14 days Both Neonates with sepsis diagnosis Blood group or Rh incompatibility between mother and neonate Direct hyperbilirubinemia Major congenital anomalies Need to exchange transfusion at the time of admission previous use of drugs like phenobarbital or cotoneaster History of previous exchange transfusion Previous phototherapy Infants of diabetic mother Spherocytosis or elliptocytosis in peripheral blood smear Evidence of severe hemolysis, Retic≥5% P59.8 Neonatal jaundice from other specified causes Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Neonates receiving phototherapy and Ursodeoxycholic acid (10 mg / kg / day every 12 hours to 48 hours). Ursodeoxycholic acid is a 300 mg capsule manufactured by Kushan Pharma Co., Tehran with generic name of Ursobil is given to the neonate with a specific dose solutes in 2 cc of breast milk . Intervention group 2: Neonates receiving phototherapy and Ursodeoxycholic acid (20 mg / kg / day every 12 hours to 48 hours). Ursodeoxycholic acid is a 300 mg capsule manufactured by Kushan Pharma Co., Tehran with generic name of Ursobil is given to the neonate with a specific dose solutes in 2 cc of breast milk . Control group: Neonates receiving phototherapy and placebo (breast milk). Mean total serum bilirubin level based on Mg/dl. Timepoint: 12, 24, 48 and 72 hours after intervention. Method of measurement: With the Diazo method and the kits of Tehran Pars َAzmoon Co. The percentage of total serum bilirubin reduction to the initial bilirubin. Timepoint: 24 hours after admission. Method of measurement: With the Diazo method and the kits of Tehran Pars Azmoon Co. Duration of phototherapy. Timepoint: At discharge time. Method of measurement: Phototherapy's timer to hour. Duration of admission. Timepoint: At discharge time. Method of measurement: Patient's file observation and documantation. Duration of intensive phototherapy. Timepoint: At discharge time. Method of measurement: Patient's file observation and documantation. Need to exchange. Timepoint: During admission. Method of measurement: Patient's file observation and documantation. Need to re-hospitalization after discharge. Timepoint: 14 days of life. Method of measurement: Patient's file observation and documantation. The necessary time in which, first total serum bilirubin level reaches to less than 10mg/d. Timepoint: During admission. Method of measurement: Patient's file observation and documantation. Mazandaran University of Medical Sciences Approved 2019-05-12 Ethics Committee of Mazandaran University of Medical Sciences Vice chancellor for research, Mazandaran University of Medical Sciences, Moallem Square. Sari Mazandaran Iran (Islamic Republic of)