Investigating the effect of Ursodeoxycholic acid and Synbiotic versus isolated phototherapy on indirect hyperbilirubinemia in hospitalized neonates under phototherapy.

Comparison of the effect of Ursodeoxycholic acid and Synbiotic versus isolated phototherapy on indirect hyperbilirubinemia in hospitalized neonates under phototherapy.

The clinical trial with two groups (intervention and control), pragmatic, double-blind, randomized.

This study was conducted to evaluate the effect of Ursodoxicillic Acid and Cynthiabacteric therapy on isolated indirect hyperbilirubinemia in hospitalized infants undergoing phototherapy in Sabzevar, Iran. Clinical observant and participants will be unaware of how they are grouped. Patients will be randomly assigned to intervention group 1 (Ursodoxicillic Acid and phototherapy), intervention 2 (Synbiotic and phototherapy) and control (phototherapy). Evaluation of the response to treatment is performed using a flame photometer at the end of the second day after the intervention for each of the three groups.

Inclusion Criteria: Infants aged 2 to 14 days, with a serum bilirubin level between 14 and 25 mg/dl and direct bilirubin of less than 2 mg/dl, with reticulocyte count in the normal range, with no Hematoma cerebral and Caput succedaneum. Exclusion Criteria: 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).

ّ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

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).

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.