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IRCT20180228038895N2 IRCT 2023-06-24 Rasht University of Medical Sciences Evaluating the therapeutic effect of ursodeoxycholic acid on the reduction of serum bilirubin in neonates with prolonged jaundice Evaluating the therapeutic effect of ursodeoxycholic acid on the reduction of serum bilirubin in neonates with prolonged jaundice: A randomized controlled clinical trial study 2023-05-31 anticipated 58 Complete https://irct.ir/trial/70884 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization process will be carried out under the supervision of the project manager and by her and with the direct supervision of the statistician and the supervisor. Children with admission criteria based on daily visits to the children's clinic are included in the study through consecutive sampling. For randomization, the quadruple random block method is used. According to the sample size of 58 and equal to 29 people in each group, 16 blocks of 4 complete blocks and one double block will be selected. The random allocation of samples is based on the sequence list that is done through the random block allocation software. Children who meet the entry criteria are randomly assigned to Group A (ursodeoxycholic acid) and Group B (control) based on the list. 3 Neonatal jaundice. Intervention 1: Intervention group: Administration of ursodeoxycholic acid capsules with a dose of 10 mg per kilogram of baby's weight daily in two divided doses to the intervention group for 5 days dissolved in cooled boiled water. Intervention 2: Control group: No medication is prescribed to the control group and they receive the recommended expectant treatment and monitoring. No - There is not a plan to make this available Justification or reason for not sharing IPD is Regarding ethical issues
public Seyedeh Azadeh Hosseini Nouri
17shahrivar hospital, Siadati ave., Namjoo street, Gaz square
Rasht Iran (Islamic Republic of) 4167811969 +98 13 3336 9026 Dr.azadehoseini@gums.ac.ir Rasht University of Medical Sciences scientific Seyedeh Azadeh Hosseini Nouri
17shahrivar hospital, Siadati ave., Namjoo street, Gaz square
Rasht Iran (Islamic Republic of) 4167811969 +98 13 3336 9026 Dr.azadehoseini@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Serum bilirubin above 10 mg/dl Indirect hyperbilirubinemia (below 1) 14 days 28 days Both Conjugated hyperbilirubinemia (direct bilirubin above 1) Disruption of TSH and T4 Clinical evidence of infection Urinary tract infection Sick neonates P59 Neonatal jaundice from other and unspecified causes Treatment - Drugs Treatment - Drugs Intervention group: Administration of ursodeoxycholic acid capsules with a dose of 10 mg per kilogram of baby's weight daily in two divided doses to the intervention group for 5 days dissolved in cooled boiled water. Control group: No medication is prescribed to the control group and they receive the recommended expectant treatment and monitoring. Total and direct serum bilirubin. Timepoint: On the day of visit and 5 days after the intervention. Method of measurement: Measurement of serum bilirubin level in serum sample in laboratory with kit. Rasht University of Medical Sciences Approved 2023-05-31 Ethics committee of Guilan University Of Medical Sciences Siadati Ave, Namjoo Blvd Rasht Guilan Iran (Islamic Republic of)