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IRCT20190105042241N1 IRCT 2019-03-07 Qazvin University of Medical Sciences Neonatal Jaundice Treatment Comparison of the simultaneous use of Orlistat and phototherapy with standard treatment in the decrease of neonatal jaundice 2019-02-20 anticipated 64 Complete https://irct.ir/trial/36700 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the present study, individuals will be randomly assigned to one of the two intervention and control groups by using the table of random numbers. There is no precondition for assigning individuals to groups. The randomization unit is Individual. Every participant will have an equal chance of being in each of the groups. Allocation concealment samples are done by the people of the center that they do not have any information about the researcher's aim. The allocation of individuals to groups will be done in an unpredictable random sequence by using the table of random numbers. The path in the random numbers table will be from left to right. Even numbers will be considered for the intervention group and odd numbers for the control group. 3 Neonatal jaundice. Intervention 1: Intervention group: Orlistat (a product of Sanafi Co. LTD at a dose of 6 mg/kg once administered as an oral suspension) and phototherapy (visible light with a wavelength of 490-490 nm using the phototherapy machine made by Zardiran Company). Intervention 2: Control group: Phototherapy (visible light with a wavelength of 490-490 nm using the phototherapy machine made by Zardiran Company). Yes - There is a plan to make this available What will be shared: All data is published in Excel format without mentioning patient names. When: The data will be released from July 2022 for one month. To whom: Medical students, researchers at medical research centers and professors of medical sciences universities Conditions: Comparison of data with other experimental data is allowed. If the article is published, mention should be made of the names of the persons who own the data. Where to obtain: The main executor of clinical trial How to obtain: Submitting a request by the applicant and submitting a letter from the authorized centers. Comments:
public Murtaza Habibi
Qods Sq., Shahid beheshti Blvd., Qazvin, Iran
Qazvin Iran (Islamic Republic of) 4595134159 +98 28 3333 4807 mhabibi@qums.ac.ir Qazvin University of Medical Sciences scientific Gelareh Roozbahani
Qods Sq., Shahid Bahonar Blvd., Qazvin, Iran
Qazvin Iran (Islamic Republic of) 5981134197 +98 28 3333 7006 g.roozbahani@qums.ac.ir Qazvin University of Medical Sciences Iran (Islamic Republic of) Term neonatal Neonatal weight between 2500- 4000 grams 2-7 days old neonatal Total serum bilirubin level 13-25 mg/dl Direct bilirubin level less than 2 mg/dL or less than 15% from total serum bilirubin 2 days 7 days Both Infants with sepsis disease meningitis congenital anomalies dehydration hemolytic disease Conjugate Hyperbilirubinemia P59.9 Neonatal jaundice, unspecified Treatment - Drugs Treatment - Devices Intervention group: Orlistat (a product of Sanafi Co. LTD at a dose of 6 mg/kg once administered as an oral suspension) and phototherapy (visible light with a wavelength of 490-490 nm using the phototherapy machine made by Zardiran Company). Control group: Phototherapy (visible light with a wavelength of 490-490 nm using the phototherapy machine made by Zardiran Company) Total serum bilirubin. Timepoint: Before starting treatment and 12 and 24 hours after starting treatment. Method of measurement: Standard protocol (Using diazo solutions and photometric method). Serum conjugated bilirubin. Timepoint: Before starting treatment and 12 and 24 hours after starting treatment. Method of measurement: Standard protocol (photometric method). Length of hospitalization. Timepoint: End of study. Method of measurement: Based on hours. Qazvin University of Medical Sciences Approved 2019-01-07 Ethics Committee of Qazvin University of Medical Sciences ِDadgostari crossroad, Shahid Bahonar Blvd. Qazvin, Iran Qazvin Qazvin Iran (Islamic Republic of)