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IRCT20181006041252N9 IRCT 2019-01-26 Sabzevar University of Medical Sciences Comparison of the therapeutic effect of Ursodeoxycholic acid and Synbiotic versus isolated phototherapy on indirect hyperbilirubinemia. Investigating the effect of Ursodeoxycholic acid and Synbiotic versus isolated phototherapy on indirect hyperbilirubinemia in hospitalized neonates under phototherapy. 2019-01-30 anticipated 120 Complete https://irct.ir/trial/36790 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was conducted based on a permutation block by a statistical consultant using random allocation software and the output sequences A, B, and C are available to the researcher, Accordingly, 20 blocks were allocated to patients, in each block, 2 from A treatment group, 2 from the B treatment group, and 2 from the C treatment group were placed. Eventually, after completing the blocks group A was treated with Ursodeoxycholic acid and phototherapy, Group B treated with Synbiotic and phototherapy, and Group C only treated with phototherapy. First, we determine all sixsome modes in which two individuals are assigned to group A and two to group B, and two to group C. Then we assign one of the digits 1 to 90 to each of the sixsome combinations (which includes ninety modes). In the next step, we must randomly select 20 blocks of six and write their combinations in succession. For this we have to make 20 samplings with replacement from a six-member community; 20 times, choose a random number between 1 and 90 and this process will continue until the end of the sampling and the difference between the three groups will not exceed a maximum of three (half the size of the block), Blinding description: Each person will be assigned a study code A, B, and C, which will only be known to the researcher of the type of groups. The clinical observant and the participants are unaware of the groups; somehow that when the patient is referred to a clinical observer, they only put the patients in groups on the basis of sequentially numbered, sealed, opaque envelopes containing the code and there is no information about the treatment given for each code as well as the participants who are infants with 2 to 14 days’ old will be unaware of the type of treatment due to lack of neurodevelopment. 3 Indirect Hyperbilirubinemia (Neonatal jaundice). Intervention 1: First intervention group: Patients in this group are treated with Ursodoxicillic acid (Alborzdarou Pharmaceutical Company) 10 mg/kg daily with phototherapy for two days. Intervention 2: Second intervention group: Patients in this group are treated with Synbiotics (Zisttakhmir company) 5 daily drops with phototherapy for two days. Intervention 3: Control group: Patients in this group are treated only with phototherapy for two days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public ِDr. Mitra Aldaghi
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9617913114 +98 51 4401 1604 Aldaghim@medsab.ac.ir Sabzevar University of Medical Sciences scientific Dr. Mitra Aldaghi
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9617913114 +98 51 4401 1604 Aldaghim@medsab.ac.ir Sabzevar University of Medical Sciences Iran (Islamic Republic of) Infants aged 2 to 14 days. Infants with a serum bilirubin level between 14 and 25 mg/dl and direct bilirubin of less than 2 mg/dl. Infants with reticulocyte count in normal range. Infants with no Hematoma cerebral and Caput succedaneum. Infants with gestational age greater than 37 weeks. Infants with birth weight more than 2500 grams. Infants without polycythemia (hematocrit over 65). Infants without underlying illness. Infants without exchange transfusion. 2 days 14 days Both Infants with low hemoglobin and positive glucose 6-phosphate dehydrogenase enzyme and Coombs tests. Infants who receive serum therapy, antibiotic therapy, and IV immunoglobulin (IVIG). Infants with abnormal peripheral blood smear tests. Infants with septicemia, Crigler–Najjar syndrome, thyroid and liver diseases. Infants from diabetic mother. Infants with direct hyperbilirubinemia, blood type incompatibility, and RH. P58.9 Neonatal jaundice due to excessive hemolysis, unspecified Treatment - Drugs Treatment - Drugs Treatment - Other First intervention group: Patients in this group are treated with Ursodoxicillic acid (Alborzdarou Pharmaceutical Company) 10 mg/kg daily with phototherapy for two days. Second intervention group: Patients in this group are treated with Synbiotics (Zisttakhmir company) 5 daily drops with phototherapy for two days. Control group: Patients in this group are treated only with phototherapy for two days. Total bilirubin. Timepoint: At the beginning of the study (before the intervention), 12, 24 and 48 hours after starting the intervention. Method of measurement: Flame photometry device. Sabzevar University of Medical Sciences Approved 2019-01-13 Ethics committee of Sabzevar University of Medical Sciences Sabzevar University of Medical Sciences, Tohid Blvd, Sabzevar city Sabzevar Razavi Khorasan Iran (Islamic Republic of)