Investigating and comparison the effect of Pedilact probiotic and Bilinaster in indirect bilirubin level in infants with exaggerated physiological jaundice

Investigating and comparison the effect of Pedilact probiotic and Bilinaster in indirect bilirubin level in infants with exaggerated physiological jaundice hospitalized in Shahid Sadougi Hospital, Yazd, 2024

Clinical trial with a control group, double-blind, randomized, phase three on 90 patients

Neonates hospitalized in the NICU of Shahid Sadoughi Hospital will be randomly assigned to three groups: synbiotic, herbal product and control. CG will only treated by phototherapy. The study will be double-blind, and the bottle containing the synbiotic product labeled "A" and the bottle containing the herbal product labeled "B" will be identified. bilirubin level, daily urine and stool frequency will be measured in both groups. The sex of the baby and the duration of hospitalization are recorded. Those who had a bilirubin level of <10 mg/dL or the discharge criteria based on the Bhutani chart The above items will be recorded by the project manager and NICU nurses in the prepared sheets.

Breastfed babies older than two days with indirect physiological jaundice need hospitalization based on Bhutani's diagram from mothers more than 35 weeks GA and weighing more than two kilograms and there is no pathological cause for jaundice such as sepsis, asphyxia, perinatal complications, dehydration, IUGR and Do not have a history of treatment with phenobarbital, IVIG and blood transfusion

Neonates are divided into three groups, one control group is only subjected to phototherapy, and one group is treated with Bilinaster herbal product and the other is treated with pedilact synbiotic, and finally the three groups are compared.

Reducing the duration of hospitalization; frequency of urination; fecal count; its dependence on gender

Randomization in the form of limited randomization through Permuted Block Randomization It is done in the form of three blocks of 30. Allocation concealment uses the Number drug container method, which uses the numbering of sheets based on a random sequence. The process of random allocation has been done by the moderator

Double bilnded research that nurses and residents knows solutions by A and B labels. Pedilact solution will be labeled A and Bilinaster solution will be labeled B and according to the same storage conditions of these two solutions, they will be placed in the relevant department in the NICU. Project managers will not be aware of the type of each solution. After obtaining informed consent and complying with ethical considerations, the infants will be divided into three groups, the control group will receive only phototherapy, and the named executives will give solutions A and B to the groups specified under the title A and B, respectively. The information of groups A and B will be written and delivered in questionnaires with A and B headers respectively.