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IRCT20190604043813N4 IRCT 2021-06-21 Shiraz University of Medical Sciences Effect of ursodeoxycholic acid in reducing hospitalization for phototherapy Evaluating the effect of ursodeoxycholic acid in reducing hospitalization for intensive phototherapy in neonates with indirect hyperbilirubinemia referred to outpatient clinics in comparison with the control group 2021-08-23 anticipated 148 Complete https://irct.ir/trial/56816 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization list with block size of 4 generates by https://www.sealedenvelope.com/simple-randomiser/v1/lists.The sample size , size of blocks and study groups are given to the system, and the system determines the order of the blocks and the order in each block in a list. The drug and placebo are arranged in a box according to the list by a pharmacist and are given to a doctor who is responsible for the research to be given to the neonates, Blinding description: The drug and placebo which are prepared in syrup and are distinguishable by A and B labels will be arrange in a box according to the randomization list by the pharmacist who has no responsibility for patients care . The box will be given to a doctor who is unaware of the intervention type and he give the treatment in specified order . Caregivers, physicians are not aware of the treatment. The results are compiled and analyzed by a statistician who is not aware of the intervention type. 3 Neonatal indirect hyperbilirubinemia. Intervention 1: Intervention group:The intervention group will receive oral drug of Ursodeoxycholic acid (UDCA) 10 mg/kg (1/6cc/kg) daily divided into 2 doses every 12 hours. UDCA 300 mg capsule(provided by Alborz Darou Company, Tehran, Iran) is used for the preparation of 60 mg/1cc suspension. Both intervention and control groups receive standard phototherapy at home and the baby's eye and genitalia are covered. The drug is continued until the bilirubin level is below 3mg /dl lower than the level require for intensive phototherapy. Intervention 2: Control group: At 12 hours intervals, the control group received the same volume placebo suspension (1/6cc/kg). Both intervention and control groups receive standard phototherapy at home and the baby's eye and genitalia are covered. The drug is continued until the bilirubin level is below 3mg /dl lower than the level require for intensive phototherapy. Yes - There is a plan to make this available What will be shared: After the publication of the main article, all collected de-identified IPD can be shared. When: From the time of publication until 6 months later To whom: All people who request to access the documents Conditions: After the publication of the main article, if the source of the main study is mentioned, the data will be available for systematic review and meta-analysis. Where to obtain: hhaghighi@sums.ac.ir How to obtain: The request can be sent to the email adress mentioned above Comments:
public Hourvash Akbari Haghighinejad
Family Medicine Department, Namazi Hospital, Zand Street,
Shiraz Iran (Islamic Republic of) 7194983858 +98 71 3647 4967 hhaghighi@sums.ac.ir Shiraz University of Medical Sciences scientific Hourvash Akbari Haghighinejad
Family Medicine Department, Namazi Hospital, Zand Street,
Shiraz Iran (Islamic Republic of) 7194983858 +98 71 3647 4967 hhaghighi@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Exclusive breastfeeding, Age above 1 day Neonate born with gestational age 35 weeks or more Total bilirubin between 3 mg / dL less than the level required for intensive phototherapy treatment in the hospital and the level required for hospitalization Direct bilirubin levels below 2 mg / dL. Parent consent Infants whose parents agree not to use herbal or traditional medicines during the study period. 2 days 15 days Both Rh incompatibility Uunderlying disease such as heart and liver disease Infection and septicemia Neonate of diabetic mother P59 Neonatal jaundice from other and unspecified causes Treatment - Drugs Treatment - Drugs Intervention group:The intervention group will receive oral drug of Ursodeoxycholic acid (UDCA) 10 mg/kg (1/6cc/kg) daily divided into 2 doses every 12 hours. UDCA 300 mg capsule(provided by Alborz Darou Company, Tehran, Iran) is used for the preparation of 60 mg/1cc suspension. Both intervention and control groups receive standard phototherapy at home and the baby's eye and genitalia are covered. The drug is continued until the bilirubin level is below 3mg /dl lower than the level require for intensive phototherapy. Control group: At 12 hours intervals, the control group received the same volume placebo suspension (1/6cc/kg). Both intervention and control groups receive standard phototherapy at home and the baby's eye and genitalia are covered. The drug is continued until the bilirubin level is below 3mg /dl lower than the level require for intensive phototherapy. Hospitalization rate. Timepoint: Weekly, from week 1 to 4 after the start of the intervention. Method of measurement: Asking the parents about admission in hospital for phototherapy. Total bilirubin. Timepoint: Every 24 hours until the bilirubin reaches 3 mg / dl below the level required for intensive phototherapy. Method of measurement: Capillary method and diazo laboratory method. Adverse effect of drug. Timepoint: Till 4 weeks after the start of the drug. Method of measurement: Asking the parents about adverse effect. Shiraz University of Medical Sciences Approved 2021-05-03 Ethics committee of research of Shiraz Medical School ّFamily medicine department , Namazi Hospital, Zand street Shiraz Fars Iran (Islamic Republic of)