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IRCT20190708044158N1 IRCT 2020-02-01 Babol University of Medical Sciences Comparison between the Effect of Fenofibrate and Clofibrate on Term Neonates with Hyperbilirubinemia Comparison between the Effect of Fenofibrate and Clofibrate on Term Neonates with Hyperbilirubinemia 2019-11-08 anticipated 80 Complete https://irct.ir/trial/43678 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The neonates were allocated using a table of random numbers. In a table composed of the numbers from zero to nine after closing eyes, we pointed on a number, then moved horizontally. The number from zero to four allocated to clofibrate group and the number from five to nine allocated to the fenofibrate group. This work was continued until the end of the sample size was achieved, Blinding description: All participant neonates blindly allocated to each group, the researcher is not aware of group assignment, and also the statistician is kept blind about the results. 3 Neonatal jaundice. Intervention 1: Fenofibrate group: single dose of oral fenofibrate (Sobhan Co., Iran) in liquid form, containing 20 mg/ml, with a dose of 10 mg/kg was given at the time of admission. Standard phototherapy treatment was done. All the babies fed by their own mothers milk. Serum bilirubin level was checked at least every day at Amirkola Children's Hospital laboratory (biochemical kit, Iran) and reported as mg/dl. After reaching the serum bilirubin level to less than 10 mg/dl, neonates were discharged from hospital. Intervention 2: CClofibrate group: single dose of clofibrate (Zahravi Co., Iran) in liquid form, containing 100 mg/ml, with a dose of 100 mg/kg was given at the time of admission. Standard phototherapy treatment was done. All the babies fed by their own mothers milk. Serum bilirubin level was checked at least every day at Amirkola Children's Hospital laboratory (biochemical kit, Iran) and reported as mg/dl. After reaching the serum bilirubin level to less than 10 mg/dl, neonates were discharged from hospital. Yes - There is a plan to make this available What will be shared: The outcomes including the serum bilirubin level in two groups at the end of the trial . When: Six months after the publication of the paper. To whom: Now for the researcher at the scientific and academic centers. Conditions: For using the data to answer the unsolved questions regarding the research. Where to obtain: Mouasa Ahmadpour-kacho No 19, Amirkola Children's Hospital, Amirkola, Babol Cellphone: +989111122855 Tel. No: +98 1132354951, Email: mousa_ahmadpour@hotmail.com Fax: +981132340656 How to obtain: Sending an Email to the corresponding person, explaining the request, recognizing the applicant by the corresponding person ,then sending the data to him/her. Comments:
public Mousa Ahmadpour-kacho
No 19, Amirkola Children's Hospital, Amirkola
Babol Iran (Islamic Republic of) 4731741151 +98 11 3235 4951 mousa_ahmadpour@hotmail.com Babol University of Medical Sciences scientific Mousa Ahmadpour-kacho
No 19, Amirkola Children's Hospital, Amirkola
Babol Iran (Islamic Republic of) 4731741151 +98 11 3235 4951 mousa_ahmadpour@hotmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Term neonates(37 weeks to 41 weeks and 6 days) that their ages are more than 72 hours. They were admitted for jaundice, total bilirubin serum more than 15 mg/dl. They were otherwise healthy. They did not receive therapy other than phototherapy. 3 days 28 days Both Premature neonates IUGR infants Neonates with congenital anomaly Neonates with blood group and RH incompatibility Neonates with G6PD deficiency Neonates with history of maternal phenobarbital consumption Neonates with respiratory distress and signs and symptoms of sepsis P59 Neonatal jaundice from other and unspecified causes Treatment - Drugs Treatment - Drugs Fenofibrate group: single dose of oral fenofibrate (Sobhan Co., Iran) in liquid form, containing 20 mg/ml, with a dose of 10 mg/kg was given at the time of admission. Standard phototherapy treatment was done. All the babies fed by their own mothers milk. Serum bilirubin level was checked at least every day at Amirkola Children's Hospital laboratory (biochemical kit, Iran) and reported as mg/dl. After reaching the serum bilirubin level to less than 10 mg/dl, neonates were discharged from hospital. CClofibrate group: single dose of clofibrate (Zahravi Co., Iran) in liquid form, containing 100 mg/ml, with a dose of 100 mg/kg was given at the time of admission. Standard phototherapy treatment was done. All the babies fed by their own mothers milk. Serum bilirubin level was checked at least every day at Amirkola Children's Hospital laboratory (biochemical kit, Iran) and reported as mg/dl. After reaching the serum bilirubin level to less than 10 mg/dl, neonates were discharged from hospital. Serum bilirubin level. Timepoint: Admission time, second day, third day, discharge time. Method of measurement: Spectrophotometric method with the biochemical kit ( made in Iran ). Duration of need to phototherapy and hospital stay. Timepoint: From the time of admission until discharge. Method of measurement: Duration of time by hour. Babol University of Medical Sciences Approved 2019-11-03 Ethics committee of Babol University of Medical Sciencese Vice-chancellor for Research Technology Affairs, Babol University of Medical Sciences, Ganjafroz Street Babol Mazandaran Iran (Islamic Republic of)