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IRCT20180311039048N1 IRCT 2023-12-23 Zanjan University of Medical Sciences The effect of probiotics on indirect bilirubin levels The effect of probiotics on indirect bilirubin levels in neonates with neonatal jaundice in neonates hospitalized to Ayatollah Mousavi Hospital in Zanjan 2023-12-22 anticipated 120 Complete https://irct.ir/trial/73368 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be simple. In order to have equal and independent conditions for all samples and eliminate any type of bias, a simple random method will be used to select samples in the intervention and control groups, which means that some people will be offered the use of probiotics completely by chance. The baby will be first explained to the parents about hospitalization, then a dice will be thrown, and if the dice number is even, he will enter the treatment group with probiotics, and if the number is odd, he will be treated with common treatments. Random allocation is done using Excel software. For this, in the first column, we enter 61 numbers 1 and 61 numbers 2 (representing the probiotic group and common treatments, respectively). Then, in the second column, we generate 122 random numbers using the RAND() function. We sort the data based on column values ​​containing random numbers (ascending or descending). With this sorting, the order of placement of numbers 1 and 2 will also change and be placed randomly. Based on the order of appearance of numbers 1 and 2, the samples are assigned to two groups. 3 Jaundice in babies. Intervention 1: Intervention group: For the treatment of newborns, 5 drops of Procid brand probiotic will be used daily, and the medicine will be prescribed for 3 days. Intervention 2: Control group: This group of babies will receive routine treatments, including phototherapy and serum therapy, and Peroxide drops will not be used for these babies. Yes - There is a plan to make this available What will be shared: All data will be accessible after de-identifying individuals When: Beginning of the access period from 2025 To whom: Researchers Conditions: It will be accessible by mentioning the source Where to obtain: It will be available via email after correspondence How to obtain: After the correspondence, it should be available within a week Comments:
public Azam karimi Asl
Gavazang Mosavi Hospital
Zanjan Iran (Islamic Republic of) 5618345139 +98 24 3331 0000 karimi.aazam@yahoo.com Zanjan University of Medical Sciences scientific Azam Karimi Asl
Gavazang Mosavi Hospital
Zanjan Iran (Islamic Republic of) 5618345139 +98 24 3331 0000 Karimi.aazam@yahoo.com Zanjan University of Medical Sciences Iran (Islamic Republic of) 1- Infants suffering from neonatal jaundice who have referred to Mousavi Zanjan Hospital and are indicated for hospitalization. 2- Babies for whom no fetal anomalies were mentioned before birth. 3- Babies whose jaundice is not pathological. 2 days 2 months Both 1- Babies whose jaundice started on the first day 2- Babies whose jaundice is related to biliary atresia 3- The baby's family is not satisfied. P59.9 Neonatal jaundice, unspecified Treatment - Drugs Treatment - Drugs Intervention group: For the treatment of newborns, 5 drops of Procid brand probiotic will be used daily, and the medicine will be prescribed for 3 days. Control group: This group of babies will receive routine treatments, including phototherapy and serum therapy, and Peroxide drops will not be used for these babies. The amount of indirect bilirubin that led to hospitalization. Timepoint: The first day of hospitalization, the second day of hospitalization, the third day of hospitalization. Method of measurement: By laboratory kits through blood sampling. Zanjan university Approved 2023-03-12 Ethics committee of Zanjan university of Medical Sciences Gavazang Street, Zanjan University of Medical Sciences Zanjan Zanjan Iran (Islamic Republic of)