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IRCT20210201050199N1 IRCT 2021-04-03 Rasht University of Medical Sciences Therapeutic effect of oral ursodeoxycholic acid on indirect hyperbilirubinemia in full-term neonates undergoing phototherapy in hospital 17 Shahrivar - a randomized controlled clinical trial Therapeutic effect of oral ursodeoxycholic acid on indirect hyperbilirubinemia in full-term neonates undergoing phototherapy in hospital 17 Shahrivar - a randomized controlled clinical trial 2021-04-19 anticipated 106 Complete https://irct.ir/trial/54987 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization before the start of the program will be done by the software https://www.sealedenvelope.com with 53 people in each of the 2 groups (Urso and Photo and Control groups) in blocks of 4 and each of them inside A separate envelope is placed according to the list obtained from the software and is closed in it and will be given to the third person. If the patient visits and is eligible, the envelope is opened and treated according to the desired sequence without knowing the next treatment. . It should be noted that according to the grouping performed, patients will be divided into 2 groups based on random assignment done with the software. It is the responsibility of the pediatric resident to evaluate other variables and variables related to hyperbilirubinemia and to evaluate the side effects of the drug on a daily basis during hospitalization. Group A will receive oral Urso with phototherapy and group B will receive phototherapy alone (control). • 1, 4, 1, Group B • 1, 4, 2, Group B • 1, 4, 3, Group A • 1, 4, 4, Group A • 2, 4, 1, Group B. 3 Hyperbilirubinemia. Intervention 1: Intervention group: those who will receive oral Urso with phototherapy (administering Urso orally at a dose of 10 mg/kg in divided doses every 12 hours and at the time of hospitalization dissolved in breast milk). Intervention 2: Control group: those who will receive phototherapy alone. No - There is not a plan to make this available Justification or reason for not sharing IPD is Regarding the ethical issues and confidentiality
public Manijeh Tabrizi
Siadati
Rasht Iran (Islamic Republic of) 4144444444 +98 13 3336 9002 drs.tabrizi@gmail.com Rasht University of Medical Sciences scientific Manijeh Tabrizi
Siadati
Rasht Iran (Islamic Republic of) 4144444444 +98 13 3336 9002 drs.tabrizi@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Parents' complete satisfaction with the presence of children in the study Birth weight 2500 to 4000 grams Exclusive breastfeeding, Gestational age 38 to 41 weeks Age 3 to 7 days Total bilirubin 14 to 20 and direct bilirubin less than 2 3 days 7 days Both ABO and RH incompatibility G6PD enzyme deficiency Direct hyperbilirubinemia Septicemia Diseases leading to hyperbilirubinemia (carpenter Kriegler syndrome, Gilbert syndrome, hyperthyroidism, hypothyroidism, liver disease) Preterm Neonate of mothers with gestational diabetes mellitus E80.6 Other disorders of bilirubin metabolism Treatment - Drugs Treatment - Drugs Intervention group: those who will receive oral Urso with phototherapy (administering Urso orally at a dose of 10 mg/kg in divided doses every 12 hours and at the time of hospitalization dissolved in breast milk) Control group: those who will receive phototherapy alone Total bilirubin. Timepoint: Every 24 hours. Method of measurement: Autoanalyzer device. Indirect bilirubin. Timepoint: Every 24 hours. Method of measurement: Autoanalyzer device. Rasht University of Medical Sciences Approved 2021-03-03 Ethics committee of the vice chancellor of Guilan University of Medical Sciences Siadati rasht Guilan Iran (Islamic Republic of)